Medical Device Compliance Professional

1 week ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €110,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to fill a key role in our organization. The successful candidate will be responsible for post-market activities for medical devices, supporting departmental regulatory processes and procedures, and ensuring compliance with global regulations.

Key Responsibilities:
  • Support regulatory strategies for OUS medical devices and combination products
  • Author and review regulatory documentation, including CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports
  • Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products
  • Provide technical review of data and reports to ensure scientific rigor and accuracy
  • Collaborate with cross-functional teams and external stakeholders to provide guidance and issue resolution
Requirements:
  • Bachelor's Degree in science, math, engineering, or related discipline required; Master's Degree preferred
  • 5+ years of medical device regulatory experience, with experience in EU MDD, EU MDR, and US FDA regulations
  • Strong decision-making, communication, and technical writing skills
  • Ability to work independently and manage multiple priorities
Preferred Knowledge, Skills and Abilities:
  • Established scientific and quality expertise
  • Experience in direct engagement with regulatory authorities
  • Regulatory compliance competency in Quality Management Systems

Travel Requirements: Up to 13 business days per year



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