Regulatory job in pharma vs. medical device

Shawna

Starting to get Involved
#1
Can fellows here give some suggestions about the regulatory job in pharma vs. medical device in aspects like available job opportunity, salary, the bottle neck or ceiling, future, and whether it is easy to have your own business/company?
 
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chris1price

Trusted Information Resource
#2
Hi, maybe I can chime in, I was QA/RA manager in medical device companies for the last 20 years or so, before moving to take up supplier quality/audit for a large pharma company. First thing that stands out in pharma is that regulatory is completely different departments from quality and that QC is very separate from QA. Having said that, there is still a lot of opportunity to move between departments, indeed it is encouraged. Salaries for QA and RA are maybe higher in pharma than MD and there are plenty of jobs around.

Very much equal opportunities in both, and although I have not counted, within my current pharma company, there appears to be more females than makes in bit quality and regulatory.

Although I have not personally done it, starting a MD company would be straightforward manufacturing exercise while starting a pharma company much more difficult.
 

Shawna

Starting to get Involved
#3
Hi, maybe I can chime in, I was QA/RA manager in medical device companies for the last 20 years or so, before moving to take up supplier quality/audit for a large pharma company. First thing that stands out in pharma is that regulatory is completely different departments from quality and that QC is very separate from QA. Having said that, there is still a lot of opportunity to move between departments, indeed it is encouraged. Salaries for QA and RA are maybe higher in pharma than MD and there are plenty of jobs around.

Very much equal opportunities in both, and although I have not counted, within my current pharma company, there appears to be more females than makes in bit quality and regulatory.

Although I have not personally done it, starting a MD company would be straightforward manufacturing exercise while starting a pharma company much more difficult.
Thanks much for sharing your experience. Many consulting firms are dealing with Medical device RA/QA rather than pharma. Maybe pharma usually has its own RA/QA team. As medical device is rising, maybe it has more job chances and it is easier to start up a consulting firm for RA/QA people.
 

chris1price

Trusted Information Resource
#4
At least in UK/EU, there is a great demand for regulatory staff. There are plenty of openings for anyone who can claim experience or knowledge of MDR.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#8
Most of med device M&A took place a decade ago. Today there is significant M&A in pharma. Its not the best place to be right now and talking to people in pharma they are skittish about their long term place.
 

Watchcat

Trusted Information Resource
#9
If you can easily provide some links, I'd be interested to see these. The business reports were most likely written to persuade investors that the industry is on the rise, so they will continue to invest in it. The information on job websites is written to attract candidates, because the more candidates an industry can attract, the greater the labor supply, and the cheaper the labor.

In the meantime, here is my take on the medical device industry:

Both the pharmaceutical industry and medical device industries were essentially created by Congress, when it passed, respectively, the Kefauver-Harris Amendment in 1962 and the Medical Device Amendment of 1976. Previously, drugs and medical devices were mostly just product lines manufactured by various types of industries. (This division makes wood screws; that division makes bone screws.) Those industries were attractive mostly to conservative investors (e.g., retirees looking for stable dividends from "blue chip" companies) not to speculative growth investors. The amendments created new industries that would attract new investors.

Industries have life cycles just like products. The different phases of the life cycle are not clearly separated, some companies and sectors further along than others, but I think the medical device industry is in maturity, with some shake out still going on. The last phase is decline.

To restart the cycle, common wisdom says you need either a technological breakthrough or new markets. The latter, for both pharma and medical devices, are the global markets. (The alternative is a new patient population, so COVID-19 is causing a lot of excitement among the startup crowd, but the pandemic will be over before they ever get started up.)

Pharma first found new markets (the so-called "vanity" markets, e.g., hair and weight loss) and then its new technology. Now it is rapidly morphing into a biologics industry.

Medical devices has also gone global. This is a promising job market in the near term if you speak another language and/or are willing to relocate. Otherwise, the industry must find a new technology, which is why startups are always touting their new devices as "new breakthrough technologies," when they are really just devices, and not always very new.

IVDs are following in pharma's footsteps, with molecular genetics. If that's an area in which you have, or are willing to gain, knowledge and experience, it is rising.

For traditional medical devices, the "new" technology is currently software. This trend is actually being driven much more by the software industry than the medical device industry. Software has been in decline for a long time now. It is desperate for new markets, and healthcare is one of the few it hasn't saturated yet. So now it's all about EMRs, AI, robotics, and SaMDs. If you are a software expert, this area is rising. I don't think it is going to rise nearly as high, or last nearly as long, as the software crowd would like to think, so if you are early in your career, I wouldn't count on it to put your kids through college, and definitely not to secure your retirement.

I think over the long haul medical devices will finally board the DNA train, as we approach the singularity. I think this may be far too challenging a shift for the current industry to handle. Some of the larger companies have the resources, but someone has observed that their management seems to be far more knowledgeable and experienced at "financial manipulation" than product development, So they may lack the vision, as well as the long-term commitment, since this would be a shift extending beyond the careers of those currently serving as CEOs and VPs at these companies. Seems more likely the new biologics industry will acquire bits and pieces of the device industry, as it needs them.
 
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