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Job Information

Senior Regulatory Affairs Manager

Information About this Role

Projectus Consulting are working with an ambitious and fast-growing medical device company enjoying rapidly increasing presence in international markets and an envious pipeline for new product development.

Based from their state of the art facilities in the North West they are looking for an exceptional Regulatory Affairs professional experienced in leading and mentoring an RA team to join a Senior Regulatory Affairs Manager.

You will be experienced in the requirements around class III products combined with particular expertise in the US Regulatory pathways and managing 510k clearances.

Job Title: Senior Regulator Affairs Manager

Salary: £65,000-£75,000

Benefits: Comprehensive benefits and bonus

Senior Regulatory Affairs Manager role:

  • To implement regulatory strategy for UK sites in compliance with applicable regulatory requirements.
  • To provide effective support and consultation for new product development
  • To provide clear regulatory guidance to site operations and play a key role in regulatory registrations

Senior Regulatory Affairs Manager Responsibilities

  • Leading a regulatory team, has the overall responsibility in regulatory affairs for multiple sites in UK.
  • Plan and budget of regulatory resource and cost for UK sites
  • Manage and maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices regulations.
  • Compile and maintain regulatory files such as Technical Files, Design Dossiers, PMA and 510(k) files.
  • Co-ordinating medical device vigilance and product recall.

Senior Regulatory Affairs Manager Experience

  • Science based degree or plus with relevant working experience with proven record in the medical device arena, preferably in a regulatory role.
  • Strong leadership in managing a team from multiple sites.
  • Good knowledge of European, USA, Canada, rest of the world medical Devices Regulatory requirements.
  • Experience in preparation of and obtaining 510k clearance/PMA approval would be essential.
  • Experience in preparation and obtaining Design Dossier approvals would be essential.
  • Experience in maintaining technical files would be essential.

To find out more information please apply with your CV Now or contact James Powell- 02038000509

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.

We are dedicated to finding the right opportunity for you.