Global MedTech Regulatory Strategy Expert

6 hours ago


Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time
Senior RA Specialist Med Tech

This is a unique chance to be part of a rapidly evolving medtech industry and contribute to the success of a pioneering Swedish company.

Key Functions:

  • Design and execute comprehensive regulatory strategies for medical devices throughout their lifecycle, from product development to ongoing commercial supply and maintenance.
  • Act as the main point of contact for regulatory affairs with license partners, ensuring strict adherence to laws and regulations set by healthcare regulatory agencies.

Main Responsibilities:

  • Be responsible for RA activities, including regular meetings with license partners to discuss regulatory requirements and best practices.
  • Oversee the development, creation, submission, and maintenance of product registrations for new products and licensing activities, aligning with regulatory agency expectations.
  • Conduct thorough reviews and approvals of product labeling and marketing materials to ensure regulatory compliance.
  • Prepare and submit changes or requested documentation to regulatory agencies and respond to queries and requests in a timely manner.
  • Stay informed about new and changing regulatory requirements in key markets, such as the EU and US, and communicate updates to license partners when necessary.
  • Ensure the maintenance of accurate technical files and regulatory strategies for medical devices on behalf of license partners.

This position reports directly to the Global Head of Quality & Regulatory Affairs.



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