Highly Experienced QA/RA Leader Sought

24 hours ago

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

We are seeking an experienced Director of Quality Assurance and Regulatory Affairs to lead our Quality Assurance and Regulatory Affairs functions. This role is critical in ensuring our medical devices meet global regulatory requirements and quality standards.

The successful candidate will have a proven track record of developing and leading QA/RA strategies, ensuring alignment with business goals and regulatory requirements. They will oversee regulatory submissions and communications with global regulatory bodies, including the FDA, EMA, and Notified Bodies.

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.
  • Mentor and develop the QA/RA team, fostering a culture of compliance and continuous improvement.

Qualifications:

  • 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.

For more information about this exciting opportunity, please click Apply or visit the Contact Us page for more details. We look forward to hearing from you

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