Regulatory Affairs Specialist

2 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000
Regulatory Affairs Specialist

A Career in Regulatory Compliance

As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our medical devices comply with regulatory requirements worldwide. This involves supporting day-to-day regulatory activities, handling multiple projects related to regulatory compliance enhancements, and maintaining awareness of global regulatory trends and requirements.

Key Responsibilities:
  • Support the team in obtaining and retaining country-specific regulatory registrations on a global basis.
  • Work closely with interdisciplinary team members to ensure the effectiveness of the Quality Management System (QMS) to regulations.
  • Assist in implementing MDSAP within the organisation and support the team with CE mark submissions, significant change notifications, and Notified Body interactions.
  • Prepare international regulatory filings, including 510(k) submissions and subsequent FDA correspondence.
  • Carry out other regulatory-related duties as required.
Requirements:
  • Bachelor's degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
  • Regulatory certifications in EU MDR and US FDA desirable.
  • Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards.
  • Proven track record with the ability to successfully manage projects to deadlines.
  • Experience working directly with regulatory agencies.
Why this Role is Important:

This role is critical in ensuring that our medical devices meet regulatory requirements, which in turn ensures patient safety and product quality.

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