Medical Device Regulatory Affairs Professional

1 day ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €120,000
Regulatory Affairs Specialist Role

The position of Regulatory Affairs Specialist is responsible for overseeing post-market activities for medical devices, supporting regulatory processes and procedures, authoring and reviewing regulatory documentation, and ensuring timely and high-quality execution of all deliverables.


Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with global guidelines and industry standards.
  • Author and review technical documents, such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports.
  • Conduct Post-Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products.
  • Collaborate with cross-functional teams to provide guidance on regulatory matters.
  • Provide technical expertise in the development of regulatory submissions.

Requirements:
  • Bachelor's degree in science, math, engineering, or a related field required; master's degree preferred.
  • Minimum 5 years of experience in medical device regulatory affairs or a related field.
  • Experience with EU MDD, EU MDR, ISO 13485, US FDA regulations, and other relevant regulations.

Preferred Qualifications:
  • Regulatory Affairs Certification (RAC) or equivalent.
  • Advanced degree and/or RAC certification.
  • Strong decision-making, communication, and technical writing skills.

Additional Information:
  • This role includes travel up to 13 business days per year.
  • Ability to work independently and manage multiple priorities while following established processes.

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