Regulatory Affairs Subject Matter Expert with at least 2 years experience in medical devices required by innovative medical devices company in Dublin.  You will prepare and project-manage high quality device registrations for approval by the US Food & Drug Administration and EU Competent Authorities.

Responsibilities:

  • Liaise with the FDA on product classifications, De Novo and 510k applications
  • Liaise with EU competent authorities, US FDA and Health Canada on device listing, establishment registrations, adverse event reporting and substantial changes
  • Be the Regulatory Affairs subject matter expert for Notified Body and other regulatory audits
  • Work closely with test laboratories and test method qualifications/Clinical studies/LDTs to ensure regulatory requirements are continually met
  • Work closely with the Quality team in the areas of Vigilance, Post Market Surveillance and PSURs
  • To monitor the progress of New Product Development, Renewal and Re-Authorisation submissions
  • Commission studies with Contract Research Organisations and monitor the progress of the studies to ensure the target dates are maintained
  • Contribute towards the development of the Regulatory Strategy
  • Keep up to-date with US, EU and other global regulatory guidelines
  • Build and maintain strong relationships with Regulatory Authorities, Consultants, CROs and internal departments
  • Participate in Continuous Improvement Initiatives to further develop department functions
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Customer Care)
  • Prepare status reports and metrics for assigned projects
  • Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times

Requirements:

  • Life Sciences Degree
  • 2-4 years regulatory experience
  • Excellent working knowledge of the USA and EU regulatory requirements and procedures
  • Experience in the preparation of relevant technical, safety and performance technical documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling experts
  • Experience of emerging markets / international RoW markets and regulatory filings
  • Quality control review of technical/ regulatory documents
  • Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
  • Compliance with SOPs, Change controls and regulatory best practices
  • Familiarity with electronic submissions (eCTD) useful 
  • Familiar with MS Office, or equivalent, etc.
  • Excellent written and oral communication skills required
  • Attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage
  • Project management experience – an advantage
  • Hardworking, self-motivated and with attention to detail

Please contact Emer Smith to discuss in confidence

00353578638188

emer@emtechrecruitment.ie 

Refer a Friend