My advise would be to do the following:
1) focus on skills - what skills did you use in those previous roles that transfer to device RA? plant inspections? reviewing and following guidance? partnering with technical teams to gather data needed for reg submission? etc
2) where you were involved in very analog activities - if you were involved in plant GMP compliance, say so; similarly, describe any regulatory submissions you did, or complaints you handled, or CAPA you were involved with
3) include a cover letter - this is where you can explain how what you have done parallels what is done in Medical devices - what is your approach to creating submissions, how you inform yourself on the technical details, how you interacted with teams, whatever. This is the best place to tell your story in these types of situations
4) take some classess etc. Yes, RAC could be good, but most employers will not hire solely based on that. What they DO look for is some evidence you are committed to this new area and have begun taking steps to prepare. Even reviewing CDRH Learn can be useful on a resume. You might even think about a section called "Medical Device training"
5) emphasize your Class 1 devices - were you involved in design controls? say so. reviewing DV testing - say so etc.
Ginger
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 21-Mar-2023 17:41
From: Ansley Burnett
Subject: Requesting Advice for seeking entry level medical device jobs
Hello! I am new to RAPS but not to regulatory work. I have come up through the food industry and most recently work in cosmetics, OTC drugs, dietary supplements and class 1 medical devices.
I'd like to seek employment in medical device submissions and am looking for advice on how to make my resume more attractive. I'm considering pursuing the RAC credential but if experience is more valuable, I'd like to go for that. Where would you look to get started?
Thanks in advance!
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Ansley Burnett
USA
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