Medical Device Regulatory Affairs Specialist

3 hours ago


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

This is an excellent opportunity to become part of a global medtech company with high growth potential.

Purpose:

  • Develop and execute regulatory strategies for medical devices throughout their life cycle, from product development to commercial supply and maintenance.
  • Act as the primary point of contact for regulatory affairs with license partners, ensuring compliance with laws and regulations set by healthcare regulatory agencies.

Key Responsibilities:

  • Main contact for RA activities, participating in regular meetings with license partners to discuss regulatory requirements and best practices.
  • Lead the development, creation, submission, and maintenance of product registrations for new products and licensing activities, aligning with regulatory agency requirements.
  • 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.
  • Maintain awareness of new and changing regulatory requirements in key markets, such as the EU and US, and communicate updates to license partners when necessary.
  • Responsible for maintaining technical files and regulatory strategies for medical devices on behalf of license partners.

The role reports directly to the Global Head of Quality & Regulatory Affairs.



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