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Freelance Regulatory Affairs Manager

England

Keywords

Regulatory Affairs Consulting Sales Marketing ISO 13485 Standard Product Lifecycle Medical Material Self Motivation Risk Management

Description

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:
· 6 month contract
· Full time up to 40 hours a week
· Start date - ASAP
· 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 )
  • Required to have good expertise of MDR , ISO14971 and ISO13485
Start date
11/2022
Duration
6 Months
From
EPM Scientific
Published at
27.10.2022
Project ID:
2486389
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