Senior Regulatory Compliance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeCompliance Full time €60,000 - €85,000
Job Description

We are seeking a seasoned compliance expert to oversee supplier management of third-party manufactured finished products, medical devices, and consumables. 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.

  • Implement and improve Supplier Quality processes ensuring Supplier Quality compliance to QMS and Supplier QMS for PDx, regulatory requirements, and overall process improvement.
  • Work closely with Regional Quality, Suppliers, Sourcing, and Commercial Leaders, and Supplier Quality Team to deliver improvements that minimize the Costs of Quality and Service, and factory defects.
  • Conduct reviews, perform audits, and document findings for suppliers.
  • Make supplier pass/fail decisions based on evidence and established PDx procedures.
  • Provide information and decision influence/guidance to PDx management as appropriate through escalation.
  • Manage Customer complaints related to 3rd party medical devices and accessories.
Required Skills and Qualifications

The ideal candidate will possess:

  • A Bachelor or Master Degree in Biomedical Engineering or related field.
  • Relevant experience in the Medical Devices industry in a supplier quality role.
  • Experience with the release of products and implementing new products.
  • Experience working with Sourcing, Commercial, and managing customer complaints.

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