Director of Medical Device Compliance

5 days ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €90,000 - €120,000
Lead Quality Assurance and Regulatory Affairs Director

We are seeking a strategic leader to head our Quality Assurance and Regulatory Affairs functions, ensuring medical devices meet global regulatory requirements and quality standards. Key responsibilities include developing and leading the company's QA/RA strategy, overseeing regulatory submissions, and managing internal and external audits.

Key Responsibilities:

  • Develop and lead the company's QA/RA strategy, ensuring alignment with business goals and regulatory requirements.
  • Oversee regulatory submissions and communications with global regulatory bodies including the FDA, EMA, and Notified Bodies.
  • Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other applicable regulations.
  • Lead the implementation and maintenance of ISO 13485 certified Quality Management System.
  • Ensure product development processes comply with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety).
  • Manage internal and external audits, CAPAs, and risk management activities.
  • Collaborate cross-functionally with R&D, Clinical, and Operations to ensure regulatory and quality requirements are met throughout the product lifecycle.
  • Monitor changes in global regulations and standards, and proactively update internal processes.

Requirements:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
  • Proven years of working experience in QA/RA within the medical device industry.
  • Proven experience with FDA submissions (510(k), PMA) and EU MDR compliance.
  • Strong knowledge of IEC 62304, IEC 60601, and ISO 14971.
  • Experience leading audits and managing QMS under ISO 13485.
  • Excellent leadership, communication, and project management skills.
  • Ability to work in a fast-paced, innovative environment.

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