Senior RA Specialist Med Tech Position

10 hours ago


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

This is a fantastic opportunity to join a forward-thinking international medtech company that offers exciting prospects for professional growth.

Main Objectives:

  • Drive regulatory affairs strategies for medical devices through all stages of their lifecycle.
  • Work closely with license partners to handle regulatory matters effectively, ensuring conformity with laws and regulations imposed by healthcare regulatory authorities.

Main Tasks:

  • Be the key contact for RA activities, participating in frequent meetings with license partners to share knowledge and provide insights on regulatory requirements.
  • Oversee the development, submission, and maintenance of product registrations for new products and licensing activities, guaranteeing alignment with regulatory agency standards.
  • Review and approve product labeling and marketing materials meticulously to ensure they comply with regulatory guidelines.
  • Organize the preparation and submission of changes or requested documentation to regulatory agencies and respond promptly to queries and requests.
  • Keep up-to-date with new and evolving regulatory requirements in key markets like the EU and US, communicating updates to license partners as necessary.
  • Ensure the maintenance of accurate technical files and regulatory strategies for medical devices on behalf of license partners.

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



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