Is the Regulatory Affairs (Medical Devices) market as bad as it seems? [US Market]

[Cyyruna]

Hey all,

Been a regulatory affairs professional in mainly orthopedic medical devices since the inception of my career with 6 years of progressive medical device experience. Recently, my team was laid off from a large medical device company (will not name drop here) and I've been having an incredibly hard time even landing a phone screen with a recruiter. Roughly ~200 applicants were sent and that is not including any LinkedIn "Easy Apply" roles.

The resume is not the issue since it has gone through many iterations with many seasoned med device professionals and recruiters, my skillset is extremely relevant with 510(k), PMA, and EU MDR experience along with Post Market Surveillance, and I am a US citizen with an MBA from a T20 business school.

I've went through every major medical device company's career listings, applying broadly (mainly regulatory affairs, but including post market roles too) to any role that requires 3-8 YOE and catering my resume to each job description. The main target are roles that do not require relocation; therefore, remote roles or roles within PNW. The only phone screens I've received are for roles that were presented as remote, but actually requires relocation.

There are MANY regulatory affairs roles right now; yet I can't seem to get a lead. I have two peers who are also on the search and have a similar experience. Is anyone else experiencing this right now? There can't be THAT many experienced regulatory affairs professions... right? I keep hearing from other peers how bad the tech/biotech/CS market is right now, but felt that medical devices were somewhat safe due to no big news.

It feels almost demoralizing. During the pandemic, I had to deactivate my LinkedIn due to how many recruiters reached out, many were from the medical device companies themselves and now my skillset feels insignificant.

 

[Tidge]

I have a mental model of what might be happening. First let me explain a bit about my background. I have decades of experience across different aspects of medical device design/manufacturing and the relevant regulatory landscape and quality systems. I, along with many experience colleagues, was recently laid off from a medical device manufacturer(*1)... I've been interviewing with others. I have interviewed with "classic" large public companies, venture capital groups, small "start-ups".

In my head: Many medical device manufacturers are exercising extreme caution in all aspects of their business. For rational, well-functioning businesses there are some uncertainties in finance sectors That contribute. There too many to note, but currency valuation imbalances can really do a number on financial plans. some of the places I've interviewed with are explicitly uncertain about the current regulatory schemes in Europe... others are worried about US regulators. Eventually these companies will need competent Regulatory Affairs associates... right now I see many places unsure if they even believe they are ready to get into a new market with a new device. My most recently demonstrable core competence is more-or-less "Design Controls" resulting a DHF good enough to get regulatory clearance... but my talents are best used prior to bringing in an RA group. If companies are sure about their DHFs, I simply don't think they would need much in the way of RA beyond "maintenance mode" work.

Specific to RA job searches: I know that my former employer was leveraging external "specialized RA groups" to prepare submissions and "run interference" with regulators... despite having an internal RA department (see comments above about "maintenance mode"). The results were unsatisfactory, but I don't blame the external group for how those efforts turned out. I would make sure these small specialty shops are also in your search parameters.

(*1) My former employer is a sort of special case. It has all of the "slightly normal" issues/attitudes facing the industry, also it particularly has itself in a terrible bind with respect to shareholders. The company has never lived up to its financial promises, and it has essentially been shedding/surrendering the money-making parts of the business. This is not due to a hedge-fund-like approach to assets or business strategy. Things have gotten to the point that the holding company has appears to have decided that acting like Bain Capital (there is property involved!) might be the only way to stay solvent (or get someone to buy them out?)... its been an unending and increasingly desperate set of changes to convince shareholders they didn't make a terrible mistake in buying the company.