RA/QA Manager

Taking responsibility for Importer & Distributor obligations under the EU MDR along with assisting in QA documentation development & QMS maintenance

Responsibilities

• Managing compliance of devices manufactured by the company and those products subcontract manufactured for the company, especially in the context of Importer & Distributor activities as “Economic Operators” under the EU MDR

• Managing liaison with local Distributors to ensure seamless operation of the verification process along the supply chain throughout the relevant geographic areas

• Managing roll-out and instruction of affiliates, warehousing and distributors on appropriate QMS procedures and documentation regarding, but not limited to, MDR obligations

• Site audits (internal & external) to ISO and related standards; support CAPA resolutions

Requirements

• Trained in requirements of ISO 13485, ISO 9001, GMP

• Trained in requirements of the EU MDR

• 5+ years’ experience in a Medical Device RA or QA management role

• Methodical, accurate and consistent attention to details