Regulatory Affairs Certificate (Medical Device and Pharmaceuticals

N

nmquality

#1
I am interested on getting a Regulatory Affairs Certificate (Medical Device & Pharmaceuticals).
I searched a lot and I found out that Regulatory Affairs Professionals Society (RAPS) offers exactly what I am looking for. However, I would like to know if anyone heard about (RAPS) and their online courses and certificates.
In addition, I like to know if I became a ?Certified Regulatory Affairs? will make companies more interested and confident to hire me in addition to my experience in FDA and ISO 13485 Regulations. Please advise me.
Thank you.
 
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Z

Zac_Brousseau

#3
Hi nmquality,

I work for RAPS, and I will try to answer your question. RAPS' Regulatory Affairs Certificate Program is intended to provide regulatory education and training so to meet specific learning objectives. You can pursue a certificate focused on pharmaceuticals regulation, devices regulation or both. For more info. go to the RAPS website and click on Education & Training > Regulatory Affairs Certificate Program. (Sorry, can't post a link apparently since I'm new to the forum.)

The certificate program is sometimes confused with Regulatory Affairs Certification (RAC), which is a professional credential attained by passing an exam. It is different from RAPS' certificate programs.

To get answers to more specific questions, I would suggest contacting RAPS' customer service team at +1 301 770 2920, ext. 200, or email raps at raps dot org.

Good luck!
 
J

Julie O

#4
I don't work for RAPS. As Zac notes, RAPS has both a certification and certificate programs. I'm inclined to think that employers would be satisfied with either the certification (RAC) or information on your resume that says you have completed one of the certificate programs, but you should definitely get more input on that from people working in the industry.

Speaking of "the industry," if you feel confident you are going to work in either pharma or medical devices, and would like to pursue a certificate (rather than a RAC), I would recommend the certificate program specific to the industry, rather than the dual program. Most companies want RA professional who are trained one or the other. Even companies developing combination products will often use one RA professional to handle the drug side and another RA professional to handle the device side. Most drug companies don't give much weight to device RA experience, nor vice versa.

I also recommend reviewing RA job listings online to see what is being requested...RAC (required, preferred, or just a plus?), RAC or equivalent training, regulatory degree or equivalent, etc.
 
J

Julie O

#5
PS RAPS has an associate membership that will give you access to a lot of information on regulatory affairs and on the profession, as well as to the RAPS forum, which is where you could get a lot of feedback on this question from RA professionals.
 
S

Shiva8416

#6
Hi nmquality,
did you give RAC certification? How was it? Can somebody help to understand where to start? And if anyone is willing to sell their book
 

immi

Registered
#7
HELLO GUYS
I am new to this forum. I am going to appear in RAC. but I need your suggestions
firstly I should appear in RAC USA or Canadian or Global and why? I am residing in Toronto Canada.
secondly please advise me how to prepare this exam.?
thirdly RAC is sufficient or I have to take RAP certificates?
 
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