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Principal Regulatory Affairs Specialist

Job description

Principal Regulatory Affairs Specialist | 18-month contract | Galway.

Our client, a Medical Device manufacturer is looking for a Principal Regulatory Affairs Specialist to join their team on an 18-month contract.

You will within this role support regulatory requirements for activities within manufacturing & sustain products already on the market.

The role will involve working with regulatory bodies (FDA & EU bodies) but also with colleagues throughout the globe.

 

You will within this role:

  • Identify and develop best practices within the Regulatory Affairs Department including continuous development initiatives
  • Develop strategies for earliest possible global approvals of regulatory filings
  • Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed
  • Keep up to date with regulatory procedures and changes. Develop internal procedure to ensure continuous compliance with all regulatory requirements
  • Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes
  • Lead regulatory filings to support submissions, license renewal and annual registrations.
  • Influences clinical evidence strategy to support labeling content, marketing claims and regulatory compliance.
  • Mentor and coaches’ other employees within the department and provide leadership support to ensure strong talent development
  • Engage with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products
  • Work with engineers and technical experts to develop regulatory strategies and resolve questions from regulatory agencies
  • Directs and influences the preparation of documentation to support high quality regulatory submission dossiers

 

Experience:

  • Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering, or related discipline.
  • Minimum of 6 year’s relevant experience in Medical Devices and or Pharmaceuticals.
  • Capable of managing large projects or processes.
  • You are a dynamic team player and can work effectively and pro-actively individually and in teams.

 

If you are interested in this role please apply with an updated CV to Rebecca O'Connor at roconnor@sigmar.ie

 

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