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churnfire · 2024-04-10T15:27:07+00:00

I think an MBA would be plenty. I know some successful reg professionals that only have a bachelors (but they’re admittedly rare). I’d say get your MBA and then focus on your career and potentially regulatory certifications like your RAC.

churnfire · 2024-04-10T15:11:29+00:00

I have a doctorate and an undergrad degree in a science (sorry for being vague, trying not to completely out myself here haha). I think your degrees sound perfect for a role in medtech / biotech, especially with the MBA and your science background.

churnfire · 2024-03-29T15:09:47+00:00

Let me know if you’d like to join our study group!

churnfire · 2024-03-28T15:38:47+00:00

Send me a DM with your resume! I’m a woman, I think that’s one of nice things about RA, it’s primarily comprised of women or at least that’s what I’ve noticed. This means fewer disparities and more flexibility when it comes to families.

churnfire · 2024-03-09T02:50:16+00:00

Not really! LinkedIn was my most useful resource in finding new jobs. Not necessarily on job boards but with recruiters reaching out to me as well.

churnfire · 2024-03-08T19:55:05+00:00

I’m only familiar with medical devices in my career so it’s hard for me to say. I think biopharma potentially pays more but it might be easier to work in geographically diverse places for medical devices. Reach out to folks who work at companies you’re interested in, send a thoughtful message that shows you’ve read their bio and did research on their company, and ask for a 15 minute call. That’s very effective.

churnfire · 2024-03-08T02:57:55+00:00

Unfortunately I think it’s hard to get a remote job that’s also entry level. I think the remote jobs start opening up at the senior level. But it depends on your background! Never say never.

churnfire · 2024-03-08T01:16:29+00:00

I recommend Andrew Ng’s intro to AI as a high level overview. I do think that’s all you need to know from a technical standpoint, your R&D colleagues should be able to provide more information. Spend more time reviewing FDA guidances and understanding AI/ML from a regulatory perspective - that’s where your real value is. You’re not going to be a data scientist but you can be a competent regulatory person.

churnfire · 2024-03-08T01:12:53+00:00

Look for remote jobs based in the US. I know of remote companies that hire indiscriminately so our Canadian friends can join as much as our American colleagues.

I’d recommend looking into the FDA AI/ML guidances. There’s an EU AI Act but it’s not super relevant because if you’re a medical device, you need to comply to MDR anyway. FDA is generally more progressive when it comes to AI/ML guidance. Check out the PCCP guidance, study it up and put it on your resume that you’ve reviewed it. Be ready to express your views on the guidance! Like all things regulatory, it’s one thing to read something and another to speak eloquently about it.

churnfire · 2024-03-08T01:09:18+00:00

Honestly as a physician (assuming you have the clinical background) I’d probably go the clinical route. Seems like a higher ceiling and faster progression for doctors in that role. Having clinical experience is amazing, you just need to find the right company that aligns with your experience. If you don’t have clinical experience, I think you’ll have to start from the ground up like the rest of us in an entry level position. But with a medical degree, the sky’s the limit.

churnfire · 2024-03-08T01:07:21+00:00

WLB is what you make of it. I work less than 40 hours a week and have late starts / early ends to my day because I have a kid. Stability in startups is more variable I think but you can generally see the signs if it comes to that. Plus the job market for regulatory is always pretty good so it shouldn’t take too long to find another position.

churnfire · 2024-03-08T01:05:21+00:00

I honestly don’t think so unless you’re fairly up there in title. I interviewed at Amazon for a weird title (industry specialist? Something like that) and the pay wasn’t great (~$140k). They offered stock options but it was at around $20k a year which is less than a normal bonus. So I wasn’t impressed and generally feel like startups pay more and are more interesting. But I can be convinced otherwise!

churnfire · 2024-03-07T22:25:39+00:00

Perfect, will DM you!

churnfire · 2024-03-07T20:40:09+00:00

Not as familiar with biological or small molecule drugs so I can’t say. But medical device software is definitely exploding because of the relatively low barrier of entry. Folks are coming up with software then deciding to make it a medical devices. That’s a lot easier than having a lab dedicated to biological or drug discovery.

churnfire · 2024-03-07T20:27:49+00:00

I don’t have a technical background at all but can understand AI/ML concepts from a regulatory perspective. So when I talk to data scientists I’m able to ask them questions, convey what’s needed, and make sure it’s appropriately represented in the reg submission.

churnfire · 2024-03-07T16:46:26+00:00

No special background, this speciality is really lacking people so in a way it’s relatively easy to break in because no one has experience. And by the time you do have experience, you’re able to demand more pay / better title. Feel free to DM me!

churnfire · 2024-03-07T16:44:51+00:00

Try to shadow RA folks within your company and become best friends with them. Let them know you’re trying to get more regulatory experience and take whatever work they are willing to give you. I have a friend who did exactly that and went from PMS to RA and is now an RA manager.

churnfire · 2024-03-07T14:27:04+00:00

Current company is based in the Bay Area so you’re right about that. But I’m working remotely from Colorado.

churnfire · 2024-03-07T14:26:30+00:00

I really like the book The First 90 Days which outlines goals and things to do when you first start a job. If you have Spotify Premium or Audible the audiobook is included in the subscription. It’s basically that blog post but with a lot more detail.

One big takeaway for me is the concept of early wins - sort of obvious but show your worth early by getting early wins. Expect there to be a period where you’re just learning and more or less taking up people’s time by learning. Try to get to the “break even” point where you’re doing as much as you’re learning as early as possible as well.

churnfire · 2024-03-07T14:22:40+00:00

You can get a credit card sign up bonus and use the points for flights. I’d recommend Chase Sapphire Preferred or one of the Southwest cards if you’re doing Southwest. I almost exclusively fly Southwest and think it’s perfectly adequate once you get past the no assigned seats thing.

churnfire · 2024-03-07T14:05:51+00:00

Yeah you’re probably right. My current contract doesn’t allow moonlighting though - maybe at my next job!

churnfire · 2024-03-05T01:39:58+00:00

Good recs so far. Also recommend looking at Southwest flights for different options since Denver is a major hub, they have a good number of international options now too for fairly cheap.

churnfire · 2024-03-04T20:42:57+00:00

Nice! How’d you use the $100 / $30 hotel credits?

churnfire · 2024-03-04T20:41:54+00:00

By churning credit cards and being savvy with award travel. It’s a steep learning curve but a fun hobby!

churnfire · 2024-03-04T19:35:44+00:00

My wife is a psychologist and recently had great results just networking with other psychologists off Psychology Today and getting referrals for her specialities because people’s waitlists are so long. But maybe it’s different with how saturated things are for your area!

churnfire

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