Medical Device and Combination Product Quality Leader

6 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €80,000 - €120,000
Job Title: Manager, Medical Device and Combination Product Quality Systems

The successful candidate will lead the sustainment, improvement, and globalization of quality management systems in support of medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745.

Key Responsibilities:
  • Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
  • Host external audits in the EU region, demonstrating quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
  • Conduct internal audits to assess the compliance of quality management systems in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
  • Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
  • Maintain expertise in both current and emerging regulations and standards impacting medical device and combination products.
  • Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
  • Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
  • Program-manage initiatives intended to improve and globalize quality management systems.
Qualifications:
  • Bachelor's degree, preferably in engineering, physical science, life science, or pharmacy, and a minimum of 7 years of industry experience in a GXP regulated environment.
  • ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
  • Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.

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