Regulatory Affairs specialist

Proclinical is advertising a vacancy for a Regulatory Affairs Specialist position with a leading medical devices company that has revolutionised musculoskeletal healthcare. With an extensive portfolio of products for joint reconstruction, bone and skeletal repair, sports medicine, spine, and dental reconstruction, this company has become the world's most trusted brand for leading bone and join healthcare solutions. The Regulatory Affairs Specialist will join this company in their office based in France on a 12-month contract basis.

Job Responsibilities:

• Determining MDR Classification for all devices.
• Establishing an Instrument IFU Draft concept.
• Implementing Local Procedures based on CORP Procedure.
• Updating IFUs for First Instrument Technical Documentation.
• Completing First Technical Documentation for instruments.
• Updating all Instrument IFUs.
• Completing Technical Documentation for all instruments.
• Supporting the RA Team with their daily work when needed, such as regulatory watch and technical file maintenance.

Skills and Requirements:

• A degree in a relevant field, or equivalent experience.
• Demonstrable Regulatory Affairs experience.
• Demonstrable experience with IFUs and MDR Classifications.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.
• Mid-Senior Level.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Valaince Penteng at +44 203 846 0643, or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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