Distributed Products Compliance Leader

4 weeks ago

Cork, Cork, Ireland GE HealthCare Full time
Job Description Summary

We are seeking a dynamic and experienced compliance Leader to oversee supplier management of 3rd party manufactured finished product, medical devices, and consumables; ensure regulatory compliance, and drive operational excellence within GE Healthcare's Pharmaceutical diagnostics division.

The ideal candidate will have a strong background in medical devices and supplier auditing with additional knowledge of pharmaceuticals and regulatory frameworks (EU MDR, FDA, MDSAP). Experience with digital tools such as TrackWise is highly desirable.

This is a Maternity cover 12 months contract.

Responsibilities

Job Description
  • Lead and manage the distribution operations for medical devices, and other drug delivery associated parts and services, ensuring timely delivery and optimal inventory management.
  • Oversee product lifecycle management, including compliance with relevant regulations and standards.
  • Ensure adherence to all applicable regulatory requirements, including EU Medical Device Regulation (EU MDR), FDA, and other international regulations and standards.
  • Develop, implement, and monitor compliance programs and procedures to meet regulatory and quality standards.
  • Coordinate and support internal and external audits, including readiness and corrective actions.
  • Utilize TrackWise and other digital quality management systems to document, track, and resolve compliance issues.
  • Collaborate with cross-functional teams including Regulatory Affairs, Quality, Supply Chain, and Product Development.
  • Maintain up-to-date knowledge of regulatory changes, industry best practices, and emerging trends in medical device and pharmaceutical sectors.
  • Drive continuous improvement initiatives related to distribution, compliance, and product management.

Qualifications & Experience
  • Bachelor's degree in Life Sciences, Biomedical Engineering, or related field; advanced degree preferred.
  • Proven strong experience in medical device distribution, product management, and compliance.
  • Strong understanding of pharmaceutical knowledge and its relevance to medical device operations.
  • In-depth knowledge of EU MDR, FDE, and other relevant regulatory frameworks.
  • Experience with audit processes and regulatory inspections.
  • Familiarity with digital quality systems, particularly TrackWise, or similar QMS platforms.
  • Excellent leadership, communication, and stakeholder management skills.
  • Ability to work in a fast-paced, regulated environment with attention to detail and strategic thinking.

Preferred Skills
  • Prior experience in a global healthcare organization.
  • Knowledge of other international regulatory standards.
  • Experience in implementing digital transformation initiatives within quality and compliance functions.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

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