Senior RA Specialist Med Tech

5 days ago


Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time
Senior RA Specialist Med Tech - Life Science - Global

This is an excellent opportunity to join an innovative and international Swedish medtech company with high potential at an exciting time in its evolution.

Purpose of position:

  • Responsible for regulatory strategy, guidance to the organization on regulatory affairs matters throughout the life cycle of a medical device from product development, placing product on the market, and ongoing commercial supply and product maintenance for the company's new and existing license partners.
  • Acting as the Regulatory Affairs Expert with new and existing license partners and ensuring compliance with laws and regulations set by the Healthcare products' Regulatory Agencies.

Detailed activities and responsibilities:

  • Be the main contact for RA activities, including participating in regular meetings with license partners.
  • Develop, create, submit, and maintain product registrations for the company's products during new product development and line extensions for licensing activities.
  • Perform regulatory affairs review and approval of product labeling and marketing material for new products and licensing activities.
  • Create and submit changes or any other requested activities/documentation to regulatory agencies and respond to queries and requests from those upon assignments.
  • Surveillance of new and changed regulatory requirements and guidance in key market areas such as the EU and US, and communicate such changes externally to our license partners when requested.
  • Responsible for maintaining technical files and the regulatory strategy for medical devices for license partners upon assignments.

Report to Global Head of Quality & Regulatory Affairs.

If you are interested, please contact Niklas Claesson.

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