The first question is to define the scope of Regulatory Affairs. In particular, because of my background, I have a hard time distinguishing between Quality and Regulatory. Some companies combine them in the organizational structure and others keep them separate.
Think of the practical applications. In a company that markets products in the US, Canada, and the EU there are two areas of practice. One is making the submissions to the regulators. The other is hosting audits and inspections. In both cases, there is a strong overlap between quality and regulatory.
A suggestion on the regulatory side is a RAPS certification.
A suggestion on the quality side is a Certified Biomedical Auditor from the American Society for Quality, ASQ. (They recently changed the name to better reflect the device aspect.)
A suggestion for the EU-MDR is to attend a course and receive a certificate as a QPRC.
Consider courses in auditing to specific areas such as ISO 13485:2016, ISO 14971:2019, FDA QSR, and the EU-MDR. Be careful with FDA QSR because it is about to change.
On a personal note, consider the role of the hiring manager. I would divide the resumes into two piles. Professional certifications went into the "maybe" pile. Without professional certifications went into the "probably not" pile. Degrees without certifications went into the "probably not" pile. Professional certificates combine knowledge and experience, while degrees don't necessarily include experience. (Book smart – street stupid)
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 29-Jul-2023 23:38
From: Anonymous Member
Subject: Is there any certification that can be advantageous for my career and positively impact my resume?
This message was posted by a user wishing to remain anonymous
I am pursuing an MSc in Regulatory Affairs focusing on Medical Devices at a Canadian university. I am interested in enhancing my knowledge in the regulatory field. I would like to know if there are any certifications available that would be advantageous for my career and make a positive impact on my resume.
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