Robert Poyser Sit down and develop a new CV and identify what transferable skills you have, you will be surprised. review some job specifications of the type of jobs you would like to transfer into, from that you can decide what skills gaps you have. then you need to decide if you need a couple of courses, or is it something you can grow into from within a job.

Go for a job where you are working in a team it may mean a bit of a junior position, i.e. work with people you can learn from.
Most course are far to general unless you are just out of university.

Medical industry is vast and each position will have it's different requirements.
learning ISO 13485 or medical directives, FDA requirements is some course worth attending.

when being interviewed come clean about you skills gaps and say you are looking to plug those and their company springs to mind as the ideal opportunity.

Tip: most of use when moving to a new company have a learning curve of some sort.

Hope this helps

Bill Watson The regulatory field is sufficiently complex that even purely academic based knowledge of the regulations and processes could create demand. You probably won't be able to land a management position right away, but you'd get in the door and then see how it goes. Any FDA/CE regulated company is going to have so many audits going on throughout the year that you'll get a lot of practical experience quickly.

Julie Omohundro If you want to get into design, then you want to get into RA, not QA.

Join RAPS. Then figure out the difference between their certification (RAC) and their certificate programs. I usually recommend their device certificate program over the RAC, especially for a biomedical engineer, but any kind of RA credential will probably do. And, yes, some type of RA credential can be very helpful, especially when looking for that first RA job.

You should also apply for biomedical engineering jobs, which may be easier to get, given your background. Once you are in a medical device company, you can probably transition into RA sooner or later, if you really want to.

Stacy Livingston All great suggestions! Here's a couple links that will give you a head start if you decide on the Certification route:
-http://raps.org/racprep/
-http://raps.org/education-training/online-learning/certificate-programs/medical-devices/

I agree that your technical knowledge will be valued in an organization even without going through a certification program. After updating your CV, I believe you should be able to land a job and can then decide your path for certification (if you decide you want/need it) at that time.

Best of luck!

Aaron Liang From my experience most non-management positions don't require any special designation (RAC for regulatory, ASQ for quality) but they are beneficial in demonstrating a certain level of industry proficiency. With a design background, product development positions would be the most suitable fit and also sales since a technical background is a big asset with understanding and selling some of the more technologically complex devices. If you are looking towards regulatory/quality, I think regulatory positions may be easier to fit since you would have a strong technical background to be able to assess the device design and performance/clinical testing to produce a compelling narrative about the risk-benefit of the device within the specified regulatory framework. The challenge would be addressing the lack of regulatory framework background which could be solved through some of the online accreditation mentioned above.

Ee Bin Liew my suggestion would be to apply for an internship in a medical device company's design & development department. depending on the company, you may have special skills that they need, and if you hang around the design guys long enough you'll get the hang of it :-)

getting into RA/QA would give you some knowledge about design control and all the good stuff relating to the design history file and device master records. Too theoretical, and if it's all theory and less hands on that might affect the design/development managers' impression of you..

hope it helps

Cheers,
Ee Bin

Jane Desrochers Massive thanks everyone for your helpful comments.

For anyone else interested, the Regulatory Affairs "Certification" is distinct from the "certificate" programs, as described below.

The Regulatory Affairs "Certification" (RAC) requires:
- a minimum level of experience in the field; e.g., BSc + 3years relevant work experience, MSc + 2years experience or Md/PhD/etc. + 1year relevant work experience
- qualifying exam
- agreement to Code of Ethics

A Regulatory Affairs "Certificate", e.g., in Medical Devices is a 9-course (6 month) program providing an introduction to medical device regulatory processes etc.

Hope this helps!