Regulatory Open Forum

 View Only
Rimsys 2024 RegEx AMA
Back to discussions
Expand all | Collapse all

Pain Points of an RA professional?

  • 1.  Pain Points of an RA professional?

    Posted 09-Apr-2021 08:28
    Hello - I have been in and out of the medical device RA world for 25+ years. (Well, do you ever really 'leave' it? haha!)

    I'm curious to learn what others in this group feel are their biggest pain points. Some of mine include:

    1. Constant changes to global regulations
    2. Too much admin work
    3. Searching for market entry requirements

    What are YOUR frustrations?

    ------------------------------
    Beth Lentz
    Pittsburgh PA
    United States
    ------------------------------


  • 2.  RE: Pain Points of an RA professional?

    Posted 09-Apr-2021 09:27
    Mine would be support from other departments and sometimes support from upper management as well.


  • 3.  RE: Pain Points of an RA professional?

    This message was posted by a user wishing to remain anonymous
    Posted 09-Apr-2021 10:23
    This message was posted by a user wishing to remain anonymous

    Others who challenge/want to bring in others, related to the regulatory advice I'm giving: either because they are convinced there are easier pathways, or because they are convinced we have to do a lot more or start impractical arguments with health authorities.
    Original Message


  • 4.  RE: Pain Points of an RA professional?

    Posted 12-Apr-2021 16:00
    "Others who challenge/want to bring in others, related to the regulatory advice I'm giving" - the same for me.
    Especially this is the case with people from commercial teams who start asking around (sometimes people in other companies, sometimes thier ex-collegues) and get information which is incorrect or not fully correctly understood by them. Sometimes it takes up too much time to reconvince people, and that time can be spent in much more useful ways.

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 5.  RE: Pain Points of an RA professional?

    Posted 12-Apr-2021 16:05
    Good to hear from you Oksana.  It has been a long time, no?

    Hope all is well.

    Ginger




    Original Message


  • 6.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 16:30
    Thank you, Ginger, I am doing just fine
    It is just that time flies too fast))

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 7.  RE: Pain Points of an RA professional?

    Posted 13-Apr-2021 12:00
    "Others who challenge/want to bring in others, related to the regulatory advice I'm giving" - the same for me.
    Especially this is the case with people from commercial teams who start asking around (sometimes people in other companies, sometimes thier ex-collegues) and get information which is incorrect or not fully correctly understood by them. Sometimes it takes up too much time to reconvince people, and that time can be spent in much more useful ways.


    I think this one is common because regulatory so often relies on "interpreting the gray." This means that sometimes different companies reach different determinations in areas that are similar, or even nearly identical. Some companies are more risk tolerant. One product may have a regulatory nuance (say, exact wording of Indications for Use) that another doesn't etc. Thus, we will all always hear "but so and so does it!" - which may or may not be true. I think the best we can do then is explain the rationale, give them options and hope that over time we build the trust in our opinions that we hear less of this.

    As for bringing in others, I really never minded it - I think a second opinion (from a qualified person) is well worthwhile, and I have learned a lot from them over the years which has made ME a better reg person. There are times now I even suggested it - as an executive I think it is part of my obligation to the company to explore various inputs. [note that I am not talking about finding someone who says, for instance, something with an obvious safety problem does not need to be recalled, but I will happily listen to other ideas for submissions or ad/promo strategies etc.]

    I agree with my namesake though, that there is a big difference between that and a client who "found an answer they liked better" and then wants you to clean it up later.

    Ginger (the other one)

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 8.  RE: Pain Points of an RA professional?

    Posted 11-Jun-2021 11:08
    Hi Liz - do you mean lack of support from those groups? How are they not supporting you - what is missing? I'm going to guess resources but I'd love to hear what you're thinking.

    ------------------------------
    Beth Lentz
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------

    Original Message


  • 9.  RE: Pain Points of an RA professional?

    Posted 09-Apr-2021 13:59
    Great question!

    Mine are:
    1. Under-resourcing of the RA department & lack of scaling in relation to the growth of other areas of the company
      • Related: Communicating resourcing needs to upper management
    2. Over-reliance on regulatory consultants rather than hiring FTEs (consultants are useful for high level strategy but not for execution of work (admin and/or operations RA tasks) that would be better suited for entry- to mid-level regulatory people
    3. Challenges from marketing about claims
    4. Figuring out where regulatory ends and related functions (quality & clinical) begin in times of high workloads. But when things are calmer, this is a positive because it allows for stretch assignments!
    I think most of these are small company issues with the exception of #3. I'm interested in hearing some perspectives from regulatory folks at large companies.

    ------------------------------
    Hiral Dutia
    Regulatory Affairs Manager
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------

    Original Message


  • 10.  RE: Pain Points of an RA professional?

    Posted 10-Apr-2021 06:19
    Finding the right people for the risk tasks/jobs/career.  I have found over the years, some people have "aptitude" for certain activities, maybe more what they enjoy, so finding those strong points in regulatory world is tough - working in quality and regulatory can be challenging in and of itself.  If a person ends up getting "stuck" in validations when they are a more creative person or like working with statistics then they end up not liking their job too much.  Easy enough said, if you do not like your job, does not make you happy.  Hopefully people can find their happiness in their job !

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 11.  RE: Pain Points of an RA professional?

    Posted 11-Jun-2021 11:37
    Hi Richard - yes, that is very true and I am proof. I worked for a large medical device manufacturer for many years, different roles, but never really found my happy place there. I always gave it my best though and it was a good learning experience by not being siloed in one area.

    ------------------------------
    Beth Lentz
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------

    Original Message


  • 12.  RE: Pain Points of an RA professional?

    Posted 15-Jun-2021 00:34
    Edited by Millie Sifuna, MS, RAC 15-Jun-2021 00:38
    I have wondered if perhaps rotational training can help identify strong areas and encourage development in others. As a beginner, I have dabbled in devices and drugs but lean towards drugs because I noticed 'fatigue' in staff stuck in certain roles of the devices' companies.   I have keenly asked at interviews if rotational training was possible even in Reqgulatory/quality areas and most device employers came up short.

    ------------------------------
    M] [S]

    Newton Highlands MA
    ------------------------------

    Original Message


  • 13.  RE: Pain Points of an RA professional?

    Posted 10-Apr-2021 07:50
    As a consultant,  my pain is companies who ghost you, go to someone else, then come back 2 years later after a really bad outcome using someone else, still at the same point they were at and expect you to prioritize their project, because you are familiar with them.

    Ha ha, nope. This is the equivalent to large companies who don't rely on internal RA or QA but will pay outside consultants the 3x the money for the same advice but internal RA/QA still do the  work.


    I have been in many very small companies (7-8) and been a contractor for temp agencies for periods when I moved across the country or quit jobs without another lined up.  I was at 3M supporting most of their health care divisions for 13+ years over 2 periods of time.  Management not believing in their own people and not developing them (no mentoring, training, conferences) is the biggest common pain finding.  There are many pain points in RA but the worst is working for non-supportive management.

    (Butthe "told ya so" moments are satisfying).


    Hence, I work for myself.  �� clients and regulatory agencies I can handle. My business,  my rules. At some point you walk away (retirement), but in the interim, it's a very interesting career.



    Original Message


  • 14.  RE: Pain Points of an RA professional?

    This message was posted by a user wishing to remain anonymous
    Posted 12-Apr-2021 11:11
    This message was posted by a user wishing to remain anonymous

    In a medium-size company, it's challenging to explain the regulatory function, and sometimes to define where its boundaries should be.
    • Human Resources tends to see it as an administrative support function and wants to staff it with file clerks rather than paying for regulatory professionals.
    • Marketing tends to see it as ad/promo support and wants it to manage the claims and images content database.
    • Sales tends to see it as international business support and wants it to prepare tenders.
    • Quality tends to see it as kindred and wants it to take on their excess work.
    • Engineering tends to see it as a support function and wants it to take on document management, design control training, electrical safety testing, biocompatibility documentation, etc.
    • Almost everyone tends to see it as a bad guy, inventing constraints and making them write documents!

    Then there are the ordinary challenges of the profession itself.
    • Keeping up with changing regulations.
    • Judging how to interpret unclear guidance.
    • Making quick changes when needed.
    • Communicating the strategy, in line with the company's culture.

    And the ordinary challenges of the business environment.
    • Managing the workload.
    • Negotiating for resources.
    • Working effectively across different cultures and styles.
    • Coping with natural disasters or toxic colleagues.
    • Managing your career and your personal aspirations.
    ​
    Original Message


  • 15.  RE: Pain Points of an RA professional?

    Posted 12-Apr-2021 11:22
    Very well written

    Ginger Cantor 




    Original Message


  • 16.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 16:28
    "Human Resources tends to see it as an administrative support function and wants to staff it with file clerks rather than paying for regulatory professionals."It is sad to read that. I am very familiar with this as we used to have the same issues with HR people in Russia 4-5 years ago, but not anymore. However, nowdays we have such a challenging regulation and so many regulatory obstacles that everyone is very picky hiring RA people.  It is alway a pain for HR to find those people, though, so they are actually rather reluctant if you want to fire someone (even the worst ones). Normally HR will always defend RA people and try to resolve any issues with other functions.)


    ​

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 17.  RE: Pain Points of an RA professional?

    Posted 11-Jun-2021 11:50
    Hello - very interesting observation.

    In the first set of bullets, I find that analogy interesting. Where I used to work, a large medtech company, those borders were more defined. However, regulatory had their hands in everything! Nothing was happening without their involvement. Its common for smaller companies to share the responsibilities until you're at a  stable place where they can be appropriately delegated.

    ------------------------------
    Beth Lentz
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------

    Original Message


  • 18.  RE: Pain Points of an RA professional?

    Posted 15-Jun-2021 15:19
    I couldn't have said it better. I'd like to think other's view of RA is at least beginning to change with recent regulatory hurdles

    ------------------------------
    Vidya
    USA
    ------------------------------

    Original Message


  • 19.  RE: Pain Points of an RA professional?

    Posted 12-Apr-2021 16:11
    Interesting... In Russia it is the same: it is very difficult to convince upper-management to approve additional positions or even simply raise salaries a little, rather than approve consulting work.

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 20.  RE: Pain Points of an RA professional?

    Posted 11-Jun-2021 11:24
    Hello Hiral -
    Ah yes, the love / hate relationship between Marketing and Regulatory. hahaha! I've been in both groups so I can see both sides. But for those who haven't been in a regulatory role, it's hard for them to understand the rules that must be followed.

    ------------------------------
    Beth Lentz
    RIMSYS
    Pittsburgh PA
    United States
    ------------------------------

    Original Message


  • 21.  RE: Pain Points of an RA professional?

    Posted 14-Jun-2021 11:51
    Definitely a challenge! I've found it's a relationship that improves over time, once you get to know the people in the other function.

    ------------------------------
    Hiral Dutia
    Regulatory Affairs Manager
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------

    Original Message


  • 22.  RE: Pain Points of an RA professional?

    Posted 12-Apr-2021 17:07
    Regarding the apparent dismay voiced about the notion of paying consultants 3x more, I'd like to mention that when a company hires a consultant, the company is liberated from the costly intangibles involved in the total compensation equation for full-time headcount.  For example, consultants alleviate the organization from the logistical, administrative, and financial costs of health insurance, retirement plans, liability insurance, unemployment insurance, the employer's portion of payroll taxes, office space and equipment, IT infrastructure, professional development (certifications, training, etc.), vacation time, sick time, and so on and so forth.  While it may be true from purely an hourly standpoint to say that consultants are paid 3x more, that assertion fails to give fair account of the substantial additional costs involved in the total compensation package received by full-time headcount.  Moreover, consultants must be more accountable for their time spent working for the company, whereas full-time headcount can more easily be idle at times while still collecting a paycheck.  I think these are some of the reasons that companies may oftentimes be more comfortable hiring things out to a trusted expert on a contract basis instead of biting off the substantial costs involved with full-time headcount.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 23.  RE: Pain Points of an RA professional?

    Posted 13-Apr-2021 12:08
    Kevin,

    You make valid points as to considerations of FTEs vs consultants, though I think the best reason(s) to hire a consultant are

    1) they have expertise you don't have in - house
    2) you don't have quite enough work to justify a "whatever" skill set in -house

    I think that what people were "complaining" about though, was the tendency of some in management to hire consultants only when they don't believe, or don't want to believe, their in-house team. I saw that here and there over the years. However, regulatory is a sufficiently complex professional area that I think there will always be good expertise reasons to hire consultants. As I said in another post, as the RA leader/professional, I often advice it - I know I am not the "expert" on many things, may not be up-to-date on regulator thinking on a topic in a current role, or, quite frankly, just might benefit from brainstorming as to potential ways to do something that I hadn't thought of. I think many regulatory leaders and professionals realize this as well.

    For those who have companies who do this, I encourage you to ask "can I find a way to benefit from this" rather than being resentful. Ask to sit down with the consultant and discuss. I have rarely, if ever, met one who wasn't interested in talking to the "people on the ground" and you might both learn something and have a new person in your network you may benefit from someday.

    Ginger

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 24.  RE: Pain Points of an RA professional?

    Posted 13-Apr-2021 13:27
    Edited by Kevin Randall 13-Apr-2021 13:28
    Hey Ginger,

    Thanks for your post; very informative as always.  Indeed, there are certainly good reasons and not-so-good reasons to hire a consultant; yet my post was instead intended to express my pain point about the dismay often voiced, as it apparently was in this thread, regarding consultant hourly rates.  It's not uncommon for eyebrows to raise, and for folks to feel that consultants are rolling in dough due to the consultant's relatively higher hourly rates.  I think that such perspectives need to be tempered with fair consideration of the exorbitant employment expenses and admin (only a partial list of which I provided) being handled by the consultant rather than the hiring company when the company hires on a contract basis.  I think that tends to balance out the comparison of total compensation between FTE and contractors.

    All the best,
    Kevin

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 25.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 06:33
    I agree with the two Gingers and Kevin (about the money).  Having been a consultant for almost 40 years and holding senior positions in industry for an additional 10 years I have seen and felt the responses from both perspectives.  Bringing in a consultant when competent staff exists can be interpreted as getting a second opinion or confirming the in house staff position.  However realistically the consultant may act as a threat to the in-house staff or at least perceived as such.  There is both a psychological affect and possibly a challenge to the staff professionalism.  

    At times when we are brought into a multi-billion dollar company with an extensive and very competent regulatory staff it is sometimes very surprising.  As noted by our other writers to this pain point, this is not a positive asignment with respect to company staff.  From a consultant's view the best we can do is to attempt to make the experience non adversarial for company personnel knowing and understanding that respect for in-house staff if very important.




    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------

    Original Message


  • 26.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 08:05
    I have had the benefit of working with consultants when I was at some companies.   When I worked at NovaMed, Linda Alexander was fabulous to work with when we needed clinical help for an IDE we were taking to FDA. She founded Alquest before NAMSA bought  them. Their employees were a delight to work with.

    Also when starting out, my first company GalaGen used a small CRO <50 people  that was, in fact, quite greedy and overcharged and only shared and met with our senior team of 4 (who we all called the Gang of 4).  I wrote a investigator brochure and training manual with one of our scientists  because the CRO  didn't have time to make the deadline.  We had delegated control of the clinical studies to them, so they insisted they had to review it under their obligation. We let them review it, it took them 3 weeks, delayed the trial, changed not one word of either, and charged company 25k for the review.   This was after I had already audited them and discovered they  no written procedures for running clinical practices (GCP), and they received a huge audit finding. Management chose them because they believed their "Self promotion ".    Later that year, our CEO died of a pulmonary embolism, and the two principles came to the funeral, met one hour with Senior Management  and billed the company about 10k to cover their first class travel.

    Vet what you buy from consultants, share the knowledge with employees who can benefit and develop (hmmm there's a thought - employee development) ask for value from your consultants.  

    I am not saying consultants don't bring value and that you shouldn't pay more for  that. I raised my rates after  5 years consulting and almost 30 in this industry. I am still not nearly at what I see large consulting firms bill junior consultants and I now get more inquiries since I raised my rares, which were not low before.  Ethically, bring value to clients. 

    I agree with the other wise Ginger and Robert- consultants and internal staff can collaboratively coexist (when Management values employees and includes them in the discussions with the consultant, for development opportunities).

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 27.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 08:36
    We budget quite a bit for consultants. When there is a time or esoteric knowledge need we use consultants. On the other hand, I work in a start-up so one of my goals is to build the in-house competency of the team. We just had a CER written in-house and approved by our NB so that was a win. Our MDR transition plan was written by consulting but our internal team is executing the deliverables. 

    On the negative hand, sometimes I get the sense our consultants want us to be dependent on them so they try to hijack any of the 5 hours monthly we have them on retainer to suggest they do all the work. Sometimes we use them for the full project and other times I request general direction.

    Consultants are a valuable part of our business, though.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device

    DOD/DARPA/Dept Veterans Affairs Design Controls in Research

    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 28.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 08:43
    Good to hear.  We like to think we add value.

    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------

    Original Message


  • 29.  RE: Pain Points of an RA professional?

    Posted 13-Apr-2021 14:56
    Regulations always change so that's a thorn in my side I can't help, but obtaining regulatory approvals is always a black box to me. I can submit an application and not hear back for a month or more. This creates stress in project management for our team.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device

    DOD/DARPA/Dept Veterans Affairs Design Controls in Research

    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 30.  RE: Pain Points of an RA professional?

    Posted 14-Apr-2021 17:21
    Thank you to all  the participants - I start seeing the difference between consultancy in Russia and in other countries more clearly. 
    In Russia consultants mostly do "technical work" I would say. We do not really rely on their opinion while making regulatory decisions. In-house staff is expected to have better expertise in all areas involved. Consultants  help in compiling submissions, doing routine technical work such us: filling our simple forms (e.g. try to fill in 100 positions correclty when you apply for Permit for Import to bring in testing samples))), send courriers to MoH (here everything is done in paper format, and some submissions are 1000s pages), compiling some technical files (we have ouor local format for STED, so we have to copy something from Manufacturer's papers and put in different format + add some additional information related to tests). However, in-house RA people will check all this work  and correct mistakes before submission is sent to MoH. So it is not like you can transfer some work to Consultancy and not be an expert in that.

    So far consultancies here are just trying to become actually "consultants"  in terms of helping with strategies and expertise.

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 31.  RE: Pain Points of an RA professional?

    Posted 15-Apr-2021 09:13
    Oksana,

    What you are describing we would probably in the US describe as a "contractor" rather than a "consultant." Companies do at times use both, but contractors are more typically brought in to do routine tasks under supervision of full time employees, consultants are usually brought in for specific expertise or to do more independent work. Or to provide a perspective on complex issues etc.

    Ginger G

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 32.  RE: Pain Points of an RA professional?

    Posted 12-Jun-2021 10:44

    I have read through the pain points discussed on June 11 and am in complete agreement with the ideas expressed by Beth, Liz, Hiral, Richard, Ginger, and anonymous. Permit me to share some of my own experiences.

     

    I have been a regulatory and compliance consultant with additional full-time staff for almost 40 years. Occasionally we even did clinical studies and monitor and currently audit for GCP, GMP, and GLP. Actually we've done about 360. Prior to this time I taught as an assistant professor in a medical school followed by 10 years in industry ending as a group vice president at Warner-Lambert. Most of the time I interfaced with regulatory affairs reporting directly to me or as a separate function where we worked cooperatively.

     

    From inside the company I very much appreciate the interplay of RA and marketing. Even as a consultant where we review all promotional material there really is an educational process to inform marketing people about such things as fair balance and what can and cannot be said or written in a branded piece. There can also be frictional areas between legal and regulatory. Regulatory and legal are both called upon to discuss issues dealing with the Code of Federal Regulations, guidance documents and the US code. In my experience of about 37 years in RAPS  I really never saw a discussion about legal versus regulatory responsibilities. So let me hedge my bets and say that it may have been there, but I just didn't see it.

     

    An issue which many experience in a company is when a consultant is brought in. I write now from the perspective of both working in a corporation and as a consultant who was brought in. When the company has an existing regulatory staff or individual and a consultant is hired there may be several reasons.  First, the consultant may need to confirm the RA staff judgment, the company does not appreciate in-house staff or the consultant has a level of competency that existing staff may not have. It is imperative in our judgment and experience that an outside consultant meet as soon as possible with existing staff and that management encourages it.

     

    I find it very surprising that multibillion-dollar companies who use our services have to go outside and not use their existing staff. Obviously if the company is small or does not have the capability then one needs temporary help such as a consultant.

     

    There are certain commonalities between regulatory affairs in the corporation and those of us who are consultants. I can list a few:

    1. Constant changing of regulations.
    2. The need for consistency in FDA review
    3. Clarity between legal and regulatory functions
    4. Respect and support for regulatory affairs personnel in corporations
    5. Whether it is necessary to distinguish between regulatory and quality activities and if so make the differentiation clear.
    6. Because the regulations differ in many respects from country to country harmonization will probably be necessary.
    7. Conflict between marketing and RA.

    These are just a few. Those working in a corporate environment hopefully it is comfortable and meaningful for you. Those of us in the consulting space we have the option of whether or not to take a client on or if there is a problem or concern during the project execution we will no longer work with this client in the future.



    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------

    Original Message


  • 33.  RE: Pain Points of an RA professional?

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jun-2021 17:10
    This message was posted by a user wishing to remain anonymous

    1. too much MS Word (I hate that this hasn't evolved to become more intuitive, its 2021)
    2. Little support from other functions (unless you really make a big deal out of it, thanks to MDR, it has required teams to work more closely)
    3. Under appreciated/recognized efforts
    4. Redundant company procedures related to assessments, strategies that make you spend time on things of little or no value
    5. Little investment in regulatory intelligence, clinical data - Real world clinical data is going to be the deal breaker going forward, this investment in absolutely vital for expansion!
    6. Lack of product training - this should be part of learning plan for RA professionals. We should absolutely know the materials & design of the devices we help register.

    I actually quite like the fact that we have to research market entry requirements & be up to date on global regs - isn't that part of our job? What makes us special.
    Original Message


Related Content