Medical Device Regulatory Manager

Dermal - Gosmore - Full Time

An opportunity has arisen for a Medical Device Regulatory Manager to join the Regulatory and Clinical Affairs team. The role will be responsible for providing comprehensive and broad-ranging regulatory expertise in all aspects of maintaining product regulatory compliance, as well as obtaining and maintaining medical device certification as required.

 

The role will include but not be limited to the following:

  • With a focus on medical devices, preparing and submitting applications for certification of medical device technical files.
  • Assessing, preparing, and submitting any necessary change notifications to maintain device registrations and technical files.
  • Preparing and maintaining additional supporting regulatory documentation including product literature and technical reports.
  • Preparing and reviewing documents to demonstrate compliance with regulatory standards, specifications, guidelines, and relevant codes of practice.
  • Maintaining accurate and up to date regulatory documentation including controlled documents, change control records, and SOPs in accordance with the quality management system.
  • Providing regulatory compliance guidance and support to other departments particularly Clinical Research, Pharmacovigilance, Pharmaceutical Development, Purchasing & Supply, Production, Distribution, and Sales/Marketing.
  • Liaising and fostering constructive professional relationships within the business as well as with Regulatory Authorities, Notified Bodies, industry bodies, contract manufacturers and business partners.
  • Managing, motivating, training, and developing a small regulatory team.

 

Key attributes/Skills:

  • Several years relevant regulatory experience in medical devices (preferably substance based). This experience should ideally include handling MDD/MDR technical documentation in the UK/EU, and/or experience of the regulatory equivalents in other sectors. Up to date working knowledge of regulatory guidelines, directives and other legislation is required.
  • Ability to take a helicopter approach.
  • Effective verbal and written communication skills, with the ability to present complex issues in a clear, logical, and persuasive way at all levels.
  • Confidence in both giving and defending an expert opinion.
  • Meticulous attention to detail.
  • Strong organisational and planning skills combined with the ability to work both independently and as part of a team, to defined deadlines.
  • Computer competence and experience of document management systems.
  • Ability to problem solve and work under pressure to meet deadlines.