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Regulatory Affairs Consultant - France
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Location
France
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Job type
Contract
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Salary
Negotiable
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Discipline
Regulatory
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Reference
CR/403313_1670597594
- 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
- Minimum 5 years of experience within Regulatory Affairs/Medical Devices