Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

Good morning. The impact of holding a RAC credential in the US shows that it does make a difference in compensation at all job levels. Overall, it was associated with about a 10% increase in salary for those with vs. without the credential and this impact is much more pronounced in the more junior roles, with a whopping 42% increase in salary for associates with vs without the credential. So, this would most definitely be a point for discussion with a hiring manager to see if holding a RAC credential is a nice-to-have vs a must have, as it may come with a higher price tag.  

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Austin Caudle
Senior Director
Troy MI
United States
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Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

Hi Anon,
As a hiring manager, I do take note of an applicant with multiple advanced degrees without much hands-on experience.  It can be concerning for how much practical training I would have to do if I were to hire them.  

My recommendation to you would be consider the RAC certification options and find the one that best fits your area of interest.  You can start there and expand your certifications in the future.  My reasoning is that the RAC exam requires use of critical thinking and application skills which would equate better to hands-on experience than academics.  

That's my 2 cents on my hiring philosophies. Others may differ in their thoughts.  There is no correct answer here, just what works best for you.  
Good luck!

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Sara Coon
Director, Regulatory Affairs
MN United States
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Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

I agree with the recommendation from Austin and Sara.  5 years back, i was not sure what type of higher education is required for regulatory affairs and I did the masters as well as RAC certification after that and I found it super useful and informative. Since you already have PhD, taking RAC would be the right path!

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Loganathan Kumarasamy, MS RAC
Associate Director
Scarborough ON
Canada
------------------------------

Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

Practical and real experience is critical. The more hands on and practical experience you can get to the many facets of regulatory, the more valuable you will be. The RAC is important to demonstrate strategic thinking and application. 

I would also recommend taking on the tough or more challenging opportunities as this will increase your knowledge more quickly. As you will learn, the more valuable you become, the more valuable you will be. Remember, not everything is written down and being able to apply your experience in many situations is where you need to focus.  

I look to hire proven experience, strategic thinking, scientific understanding and risk taking along with interpersonal skills focused on influence and written and oral communication. Persuasion is important. 

Good luck, 

Dar

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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

This message was posted by a user wishing to remain anonymous

As a hiring manager in the medical device space I have never put any weight in the masters or the RAC. The people I have hired with either of those have been no better prepared than other candidates. It is work experience that matters. If I were interviewing two equivalent candidates and both had no experience in RA at all, I suppose the masters or the RAC would indicate the person is legitimately interested in RA and not just applying to every position. This comment is specifically related to the device side hiring. You might find it useful even if a hiring manager does not.
Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

Hi Annonymous,
Consider yourself lucky if you are getting a tuition reimbursement. You should enroll in some regulatory-related courses. Of course, the best will be to get a RAC certification that will help advance your career in the long run. I hope this helps.

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Israr Ansari PhD, MS, RAC
Sr. Scientist - Clinical Trials
------------------------------

Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

Practical experience in the field is critical and will outweigh any degrees/certifications.  Even when I was studying for the RAC, the experience I had was important to my ability to respond to many of the questions (both technical questions and those requiring more strategic insight). You are very lucky to have a tuition benefit. I suggest taking courses to fill in some of your knowledge gaps and study for the RAC if you are up to the challenge by taking some of the RAPS online courses.  

Also, I want to point out that having advanced degrees can be helpful. I've noticed that people with advanced degrees move up more quickly in the profession speaking from a device perspective. This is especially true if you are in the premarket space where a solid scientific background may be helpful in navigating engineering concepts.

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Karen Zhou
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Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!

As you are at the very beginning of your RA career and since you have the tuition benefit, I would advice you to take more topic specific courses rather than going directly into RAC certification. Those topic specific courses will not only help you to understand the job you are currently doing on a daily basis but will also help you to build up your knowledge for your future RAC certification. Some topic specific training could be 'Training course on ISO 14971', 'Training course on Clinical Evaluation for MDR 2017/745' etc. 

Even the RAC Device Eligibility Criteria requires you to have at least a year of practical experience (with a Ph.D.). So, while you collect your work experience for the certification, topic specific courses would help you to understand the correct way to execute your role and responsibilities.

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Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan
------------------------------

Original Message:
Sent: 30-Sep-2021 14:38
From: Anonymous Member
Subject: Graduate Certificate or Master's Degree in Regulatory Affairs - worth it?

This message was posted by a user wishing to remain anonymous

Hello all,

My company just announced a tuition benefit that would allow me to take 1-2 university courses per year. I am new to the regulatory field (less than one year; I am currently a Regulatory Affairs Associate) after recently completing my PhD in a biomedical science field. I am certain that I want to stay in this career path long term.

Considering I already have a PhD, is an additional (online) degree or certificate in regulatory affairs worth it? Would future hiring managers see this as a benefit or a 'perpetual student' red flag? I wouldn't pursue a degree or certificate if it weren't for the tuition benefit, but want to make sure to use my time effectively as well. There is still some question about whether the RAPS Certificate and/or RAC prep courses are reimbursable, but if so, is this a better use of the benefit?

Thank you!