Director of Quality/Regulatory

4 weeks ago

Galway, Galway, Ireland Hobson Prior Full time

Are you a strategic thinker who is experienced in Quality Assurance and Regulatory Affairs? This Director position could be your next best move

Hobson Prior is searching on behalf of our client who are seeking an experienced and strategic Director of QA/RA to lead their Quality Assurance and Regulatory Affairs functions. This role is critical in ensuring their medical devices meet global regulatory requirements and quality standards, with a strong focus on FDA, EU MDR, and compliance with IEC 62304 and IEC 60601 standards.

Please note that to be considered for this role you must have the right to work in this location.

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, please contact Toby Shelton.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.hobsonprior.com/privacy-policy.

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