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Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
REF: 96203
Job Published: 4 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Senior Regulatory Affairs Specialist

Our client, a medical device company in Galway is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.

  • Is an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
  • Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
  • Act as a team member in product development programmes and demonstrates a good understanding of the PDP process.
  • Maintains and enhances cross-functional team relationships.
  • Review applicable Corporate SOP’s for effect on local regulatory processes and systems.
  • Prepare and maintain Technical Files and Design Dossiers.
  • Prepare and maintain FDA submissions including IDEs, 510k's and PMAs.
  • Review and approve documentation related to product release.
  • Provide input, review and approve artwork for labelling and DFU’s
  • Participate in Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities and other global regulatory agencies.
  • Liaise and provide support to international regulatory colleagues.
  • Demonstrate and actively promote highest level of professional regulatory discipline.
  • Liaises with both middle and senior management on any regulatory issues relating to their area.

  • Bachelor’s Degree in Engineering, Science or Quality Assurance
  • Experience in FDA regulations, ISO 13485 and the Medical Device Directive is required
  • Good administrative/organisational ability with attention to detail is required
  • Technical writing qualification desirable

For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 086 8395533 /

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