Senior Medical Device Compliance Specialist

4 days ago


Galway, Galway, Ireland beBeeRegulatory Full time €75,000 - €105,000
Job Description

A highly experienced Regulatory Affairs Specialist is sought to join a key role in Galway.

This role will work closely with cross-functional teams to obtain regulatory approvals for a new medical device therapy.

  • Support and advise the Quality leadership on regulatory activities and strategies.
  • Develop and submit high-quality regulatory documents to ensure timely product clearance/approval.
  • Collaborate with development teams to ensure data quality and submission goals are met.
  • Manage product design and technical documentation in compliance with relevant regulations.
  • Monitor emerging legislation and guidance, ensuring company-level awareness and compliance.
Required Skills and Qualifications
  • Bachelor's or Master's degree in a scientific or engineering discipline.
  • At least 7 years' experience in Quality Assurance or Regulatory Affairs for medical device companies.
  • Strong experience preparing and reviewing regulatory submissions.
  • Collaborative team player with knowledge of medical device design and development.
  • Excellent communication, presentation, and analytical skills.


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