Head of Regulatory Affairs

vor 3 Wochen

Genf, Schweiz Skills Alliance Vollzeit

This company at the forefront of Medical Technology; redefining Skincare

The organisation has grown year-on-year and has captured significant market share from the key companies in this space, as a result the organisation is expanding it's product range and continuing to enter new markets Their suite of products is known for excellence and so the business has been highly successful commercially across the last several years.

The company is a well-established, with multiple FDA and CE approvals across their product ranges already with MDR certification having been successfully achieved in Nov 2023 for all products.

They are now looking to hire a Head of Regulatory Affairs - EU and US

You would be responsible for Management of the Regulatory Affairs department that looks after US and EU, supporting the strategy, submissions, and associated activities for medical device products.

Your role will be to

  • Develop the regulatory strategic roadmap according to business objectives and provide regulatory leadership for programs in the pre-market and post-market space
  • Provide strategic mentorship to ensure alignment of regulatory strategies with business objectives and implementation of strategic plans
  • ensure RA excellence in collaboration with cross-functional teams by defining regulatory pathways and developing regulatory strategies for submission to Notified Body and FDA.
  • Contribute and review responses to questions raised by the Notified Body and FDA to ensure appropriate, consistent and complete answers to any question
  • Support life-cycle management activities (including change control regulatory impact assessment for EU & US regions)

They are looking for someone with:

8-10 years Regulatory Affairs in MedDevice/Pharma

Comfortable with Regulated industry and documentation for class III devices

Experience with FDA and NBs

Fluent in French

️ Passionate about making a difference and making an impact

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