Senior Quality Manager

BD
Limerick, Munster, Ireland
Full Time
Hybrid
Senior
EUR 95,200 – 145,150
Bachelor Degree
Healthcare Healthcare Life Sciences

Posted 2 days ago

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Excellent 4.7

Job summary

A Senior Quality Manager overseeing regulatory compliance for medical devices and IVD products across Europe, Switzerland, and the UK. Responsibilities include maintaining regulatory records, supporting market registration obligations, managing post-market surveillance, and liaising with authorities. Requires experience in quality systems, regulatory inspections, and relevant standards.

Responsibilities

The Senior Quality Manager will serve as the Person Responsible for Regulatory Compliance (PRRC) to ensure adherence to EU, Swiss, and UK regulatory requirements. They will oversee technical documentation, post-market surveillance, and act as the primary liaison with regulatory authorities and notified bodies.

Qualifications

EU IVDR ISO 13485 Project Management QMS Quality Systems Regulatory Affairs Regulatory Compliance Regulatory Inspection Swiss IvDO UK MDR

Candidates must hold a bachelor's degree in Engineering, Science, Law, or a related field, along with proven experience in Quality Systems or Regulatory Affairs within the medical device or IVD industries. Strong knowledge of ISO 13485 and regional regulatory frameworks is essential for this role.

English

Company

BD

BD

Medical Equipment Manufacturing
Location
Limerick, Munster, Ireland
Website
bd.com

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Excellent 4.7
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