Thank you John for initiating this dialogue!
My path to Regulatory started 17 years ago at a dental implant manufacturer in Florida. I started in Logistics, creating BOMs and routers, inspection sheets etc. After a few years, I moved to the Regulatory department where I handled domestic complaints, FDA MDR reporting etc. While I enjoyed that role and it served as a less stressful position while I pursued my Bachelor's degree, after three years, it was time to move on and accept a more challenging opportunity.
I joined the QA team as the "Label" person who was responsible for all of the company's labeling. Talk about a big responsibility! All changes to existing labels and creation of new labels were my responsibility. I particularly enjoyed that role and learned so much more as it pertained to labeling regulations, software validations and regulations, label stock, packaging specifications, etc. I spent a few years in this position and pursued my Master's degree while there.
After graduating, it was certainly time for me to explore new roles and challenges once again. While in the label role, I grew an affinity for Regulatory and regulations. Once a Regulatory Affairs Specialist position became available, I applied knowing that my chances may have been slim not having a solid Regulatory background, and the fact that I was competing against outside candidates. Thankfully, the hiring Director knew my potential, appreciated my QA background and knew that I was quite knowledgeable about various aspects of our devices. I was given the opportunity that I wholly embraced and loved every aspect of Regulatory. Within my 1st year, I authored my first 510(k) inclusive of three device types, and had only one observation via a phone call. Talk about nervous!
As life would have it and just when I was immersing myself in my Regulatory role, my husband got an opportunity in Vegas he could not pass up. I followed hesitantly of course, knowing that my chances of continuing my Regulatory career in Vegas were slim. After applying for the 1st Regulatory position that became available here, I was hired right away. Today, I am a Regulatory Compliance Specialist for a company that manufactures cosmetics cosmetic devices, adult toys and condoms. A vastly different product line than what I was used to, but I have taken this opportunity to shine in this new role and have learned so much as it relates to this industry.
Thankfully a forum like this exists as I have gained so much valuable knowledge and insight from some very seasoned colleagues on here. While my new role is sometimes challenging, this forum has been instrumental in helping me navigate my way through it all and has served as a solid avenue from which to gain much knowledge.
I thank you all, and I am so happy to be amongst such highly intellectual people with shared interests.
Cheers to much success, and congrats to everyone new to this career!
Laura
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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
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Original Message:
Sent: 14-Nov-2017 10:07
From: Sheila Austin
Subject: Tell us about yourself
I am a Regulatory Specialist in academia. I started my regulatory career as an IRB Administrator at a small university and transferred to a much larger university to continue my IRB career. While not a wildly popular position, someone's got to do it and, I really enjoyed it for 15 years. I was looking to expand my regulatory horizons so when looking for a master's program in RA to enter, I picked a specialty I needed to fill in my knowledge gap – devices (thanks St. Cloud State University and Mark DuVal among others).
I am now in the Clinical and Translational Science Institute at UF and use both my IRB and drug/device regulatory experience and knowledge to help investigators negotiate the IND/IDE process.
My work touches on issues related to GCP, GLP, and GMP and I keep my human subjects protection chops current by maintaining my IRB certification.
I too enjoy starting my day reviewing the posts on this forum.
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SheilaAustin
Original Message:
Sent: 13-Nov-2017 10:05
From: John Beasley
Subject: Tell us about yourself
Thanks for all your contributions, Mark. I sat for a short while as an observer to the TC210, WG1, for the writing one the 2nd edition of ISO 13485, so I especially appreciate your comments and insights. I purchased the "Practical Guide" a few weeks ago and the document is quite valuable. I encourage everyone to get a copy; the discussion can serve as a common point when interpreting the Standard.
Looking forward to future information from you, Mark, and everyone who is part of this Open Forum.
Original Message------
Hi John (et. al),
I am glad to contribute to this topic. As an independent consultant, I have very much appreciated my network as well. I am just coming up on 18 years in medical device. While most of my experience is in the quality side of the business, it is always a good idea to have an understanding of the regulatory and clinical aspects.
My most recent experience is as one of the contributors on TC210, WG1 in writing the third edition of ISO 13485 as well as the project co-lead (with Ed Kimmelman) for the recently published ISO handbook on that edition of the standard. I currently am a member of WG6 on the ISO post-market surveillance guidance document. Many folks from the working groups refrain from commenting on public forums out of fear of being misinterpreted or not correctly commenting. However, I have found this group to be some of the engaged individuals and I believe it is incumbent on each of us as the experts to share the information as broadly as possible. Glad to be able to contribute as I can. Cheers!
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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Regulatory and Quality Solutions
Becker MN
United States
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