I am currently working with a French Cosmetic Medical Device Manufacturer looking for a Regulatory Affairs Manager with 5/10 years of Regulatory Affairs experience based anywhere in Europe.
You will be participating in the management of Regulatory Affairs throughout the product life cycle, from design to market monitoring.
Conditions:
ยท 6 month contract
ยท Full time up to 40 hours a week
ยท Start date - ASAP
ยท Hybrid role: Some on site presence in France, Paris
Responsibilities:
- Draft regulatory registration files and ensure coordination with international Notify bodies
- Participate in marketing declarations and draft technical files (CE marking)
- Advise and assist the departments concerned on regulatory aspects (R&D, production, quality, marketing, sales, etc.); provide the applicable standards
- Dealing with technical questions from health authorities
- Check the conformity of commercial documentation and media subject to advertising control
- Participate in the risk management review
- Be proactive on the regulatory strategy (product classification, country constraints)
- Ensure the proper application of the European regulation on medical devices (MDR 2017-745)
- Required to have good expertise of MDR 2017-745, ISO14971 and ISO13485
