I'm Leaving Regulatory Affairs...
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- เผยแพร่เมื่อ 25 เม.ย. 2022
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I hope you enjoyed watching this video! I'm not leaving regulatory affairs within the pharma industry just yet but eventually I do want to branch out of pharma and move into medical device! In every industry we are focusing more on tech and I dont think the pharmaceutical industry is far behind.
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#RegulatoryAffairs #MedicalDevice #FutureOfRegulatory
LISTEN!!! Right before I saw this video pop up I literally was saying this to myself...that the future of healthcare is going to be allllll about data and tech. Corporatization has changed trad medicine sooo much and theres so many shifts that are going to create a plethora of opportunities. Currently in clinical research right now and the changes Im seeing are making me realize this more and more. Have also been seeing stuff from Meta in my Linkedin
I have a certification in Health IT. Will that become more useful when applying for regulatory affairs jobs?
@@kyabdul Yes! thank you for this!
Super super interesting. It’s crazy how fast the industry is changing. You really hit the nail on the head with being an adaptable and aware individual--or else you’ll definitely get left behind or looked over. Loved the video!
This video is beyond interesting, thank you for covering such a cool part of public health! I just got into an MPH program for epidemiology and think this is definitely the future of public health that I will be sure to consider for my career! The intersection of health and technology will definitely be booming in the next 10 years and will need public health professionals! Thank you for your content!
I needed this video. Thank you SO much ❤️ I’m going to schedule a consultation soon & explain why this video was so timely.
This video just solidify my thoughts....I have been seeing alot of medical device roles ever since I got interested in Regulatory affairs. I think medical device is the way to go. Thank you so much ❤️
Love this!!! Very futuristic and informative.
OMG this is exactly what I've been thinking about these days and you just summarized it well in a video😂 It's nice to know that I'm not the only one thinking about this! Thank you for an informative video :)
This video is so interesting and you provide some great insight to the future. I am a refractive surgery technician (LASIK surgery) and I love medical devices and technology and was considering transitioning to a clinical application specialist role so on Indeed I stumbled across a Health Tech Operations Manager role for Meta. When I read the job description essentially they want someone with an eye care background that understands managed care payment systems with specifics to vision insurance to try to get their A/R VR sets and future products with Reality labs to be covered under vision insurance. Seeing that blew my mind and I definitely realize health and tech are going to be one entity soon enough.
Kasier Permanente just launched a division in the intersection of health and tech called KP Digital! Ive also noticed that companies like Google and Meta seeking people with backgrounds in clinical science/medicine, social science research, and medical devices for jobs and positing almost hourly. I think its a great time to go be a public health or regulatory professional as theres so many transferable skills
You're so correct, the medical device space is taking over, that isn't to say that pharma is going anywhere, for the most part even pharma companies are looking to hire CRA and Regulatory affairs professionals with soft skills in data etc.
I'm currently doing my masters in Health data science and outcomes Research. I can tell you for free, 80% of my courses are tech and IT related, with the use of Big data, protection, regulatory compliance and predictive analysis tools, to shape medical device and biopharma industry.
I just started working as a reg affairs spec. In Medical devices coming from a CRO and it’s honestly hectic but I really enjoy it and there’s a lot less regulations
Thank YOU! This confirmed what I was thinking. I recently graduated from school with a PharmD. Im feeling a little lost as to "What do I want to do?". Im not interested in the typical pharmacy retail setting and Im also not sure if I should try to change careers into tech / software. I have an interview soon and having been watching all of your videos! Thank you very much! Really appreciate your content.
Best,
Megan
same feeling here..i did b pharmacy with difficulty.i think I'm interested into software or something related to technology.but i dont know how to change my future or which course should i choose.no knowledge about which course i should take.as I'm in india and planning to study in abroad.... finally am in dilama😴
@@loki3494 I was thinking the same thing about software engineer actually
Hi! Great video! 15 years ago, I transitioned from Medical Affairs in Pharma to Reg Affairs in Medical Devices. Took a few years to get my feet under me, but well worth the transition.
Health tech will certainly keep growing, but pharma will not disappear. Actually, most pharmas are taking steps to embrace the health tech space themselves. I think the intersection between health, technology, and regulatory will be very very interesting in the near future.
Wish this video existed a little while back because I also had thoughts that there is a big future behind medical devices RA compared to pharma RA but wasn’t sure what to go into and now I’ve literally just started a new job this week in pharma RA haha
This video was super helpful, I've seen the pop ups in Reg Affairs roles at FAANG, and immediately thought this is definitely the start of the future. I'm coming from a Quality Systems/Assurance background in the IVD/LDT space, any quick advice on pivoting?
@@kyabdul thanks for the feedback!
I’ve seen job postings for RA medical devices with software and robotics. Definitely a lot of room for growth and development.
Medical devices is very different from pharma indeed. I'm not intimately acquainted with the FDA process, but here in Europe the field is soooo different it's not even funny. In medical devices, the relationship with quality and marketing is much closer than it is in pharma. For those of us who work in pharma, see if you can get experience with either companion diagnostics or with combination products. It is a great way to get devices exposure.
Great advice!
Thanks for qdvice
I've been thinking about that aspect for the last few weeks! My graduate job was quality and some-very little-RA at a leading diagnostics company. However, I didn't like it that much and the salaries of the sister pharma company were higher. After 10 months, I was offered two jobs and pharma RA offered 20% more compared to a medical device company (UK).
Thinking long term, I agree technology will have an even higher influence. I can see other opportunities in Web 4.0 related to pharma - fully automated manufacturing, digital twins. I don't know yet how I could get involved (1 year generic pharma RA experience, interested in CMC) and my FOMO is real.
I've also been thinking about RIM-even asked you in one of the previous videos about it as I can see data as a part of transformation.
This is awesome I just had a review with my boss. I'm currently working with a medical device company, but my background is legal. What led me to your page my bosses mentioned growth in regulatory. But the record management class I took mentioned all of this back in 2019 regarding these apple watch can make a medical record thus it is a medical device.
Great video, I am currently working as Principal RA Specialist dealing with medicinal products and medical devices. RA for medical devices is really different from RA for drugs, but it is very interesting field.
Agreed!! This is why I got into Medical Devices early on. I will say, however, that it was a big adjustment. I have noticed that meddev is heavily engineer based and, in my experience, engineers occupy many Reg roles.
I can attest to this. I worked in Medical Devices years ago (spinal cord stimulation) and went to direct patient care. I just came back and most ALL of the new hires and roles are filled by engineers. A lot of the QA Specialists are engineers. BUT if you have a background or experience they will hire you. Which is the onky reason I was able to get back in. I only have a BS but I'm going to go back to school and get an MS in Regulatory Affairs or Biomedical Reg Affairs. A good start is as a complaint handler or product surveillance analyst (another name for that role). This role is cool bc you get product knowlege, learn what is a complaint, learn the GFE (good faith effort process), code the complaints, submit regulatory reports, submit MDR/MDVs, etc. Basically you get to see and manage the process from beginning to end. I plan to gain knowledge and experience for about a year or two max. Then leverage my healthcare clinical background with the knowlege gained to get into med device regulatory affairs.
Yes! I will also say that I still believe pharmaceutical companies are more stable than biotech. Biotech is still very new and stability has seemed to be lacking a bit from my experience… Also, I’ve noticed biotech pays less. All in all I think pharma is better for non-engineers.
I agree with the experience comment though! If you already have experience I’m sure you won’t have any issues.
Do u know of any other type of certifications or courses on med devices? Neuralink is often hiring too
Hey I have a question for you. As you know, science and biotech is a huge industry. Reg affairs, clinical research, informatics. Will companies look down on me if i apply for both reg affairs and cra roles? I think I would enjoy both.
Interesting perspective. Im currently a post-doc in RA with drug experience. I wonder how its possible to get med device exposure during FTE
The demarcation and distinction between tech and healthcare is becoming thinner and thinner and I predict both will overlap in the future
great video.....
That's very interesting. So how well RAPS Regulatory Affairs Certificate course in Medical Devices is decorated? What will you suggest to someone if they are in their early stage to take decision about RA Pharma/RA Med Dev
I am in medical device RA, it's an interesting field.
What do you recommend someone do if they are actively working in the pharmaceutical industry as a biologist but would like to break into RA? What are the first steps I should take outside of find a good RA program to get a master or certification?
Okay, thank you. Blessing to you and your many endeavors!
Hello Kyyah,
I discovered your channel a couple of months ago and really enjoy your content.
I am CRA in the medical device field and want to transition into regulatory devices.
Have you made a video discussing ways to transition into reg from within the industry?
Thank you.
@@kyabdul Thank you.
I'm in Minnesota which is huge for medical devices. But I want to move to a Biotech hub such as Raleigh or the Washington Dc area.
@@kyabdul Medtronic, Boston Scientific and 3M are just some of them
Do u think there is RA Opportunities in CANADA?
Hi Can you please provide me the details is there any universities providing PG Diploma in Regulatory Medical devices
what about food regulatory affairs?
what is RAC?
As a Reliability Engineer in a pharmaceutical company...should I give it a try in the RA?
@@kyabdul Yes...on the manufacturing/operation side.
Hi mam
I am completed my Degree in bachelor in pharmacy and I am thinking to do master in pharmacy RA which one is better
this videos is cripted beyond perfection, she had me when she opened door and camera was still rolling and the jacket lol.
Surveillance economy - hell on earth 😂 …