Regulatory Affairs Manager – Medical Device – Home Based

Apsida
Location: Switzerland
Salary: Competitive

Apsida Life Science are currently partnered with a Global Leader in the implant system space.

 

The organisation are at the forefront of their industry offering cutting edge implant technology to patients. They have a wide ranging portfolio that is marketed globally with a large amount of revenue generated being pumped back into R&D.

 

They are looking to on board a Regulatory Affairs Manager to be home based with occasional travel to the office in Switzerland. The individual will be responsible for preparation and submission for registration/CE marking and renewals across Europe.

 

Responsibilities:

  • Regulatory compliance and the maintenance of international product licenses, existing registrations/CE certifications and product technical documentation throughout the product life cycle.
  • Preparing and defending pre-market, changes and renewal submissions to obtain approvals to commercially distribute products in international markets outside of the Americas including the development of sound regulatory strategy.
  • Work closely with competent authorities and notified bodies.
  • Assistance in audits by external bodies

 

Requirements:

  • Degree in a Life Science related field.
  • Over 3 year’s experience in Regulatory Affairs or Quality Assurance
  • Previously dealt with product registrations in a medical device company for Class I, II & III products, experience with active implantable devices would be an asset
  • Fluent in English
  • Based in Switzerland or available to relocate from an EU country.

 

For further info get in touch!

The Consultant

Ethan Cortese

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