Job Details for Senior RA Specialist
What you need to know
My client a medical devices company in the Midlands is currently looking to recruit a Senior Regulatory Affairs Specialist to join their RA function due to growth.
Your new job
- You will act as a key member of the RA team
- Support vigilance on regulatory data for a range of medical devices
- Development and collation of data for submission to the notified bodies
- Support change request reviews
- Ensure continued compliance to regulatory requirements by interpretation of new medical device regulations
- Work with NPI, design teams and engineering on site to ensure device compliance
- Work with the risk management team on maintenance of risk management files
- Maintains, updates and submits any changes on product amendments
- Act as point of communication to regulatory bodies
- Perform regulatory reviews
- Participate in audits, Regulatory inspections, etc
What are we looking for?
- 3rd level qualifications related to the position
- 5+ years experience in QA/RA
- Medical devices experience
- Demonstrated exposure to leading projects/people
- Strong interpersonal skills
Apply for this job now or get in touch with Michelle on 09064 90485.
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