Manager, QARA Benelux & Nordics

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Amersfoort, Utrecht, Netherlands

Job Description:

DePuy Synthes is recruiting for a Manager, QARA Benelux & Nordics, located in Amersfoort, Netherlands

Job Overview

The Manager, Quality Assurance & Regulatory Affairs (QARA) - Benelux & Nordics provides operational leadership for quality assurance and regulatory affairs across the Benelux and Nordic markets .

This role is responsible for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes' Orthopedics portfolio in a highly regulated European environment.

T he role partners closely with local market teams, regional and global QARA colleagues, and cross ‑ functional stakeholders to manage quality and regulatory risk, support product lifecycle activities, and enable compliant business growth while safeguarding patient safety.

Key Responsibilities



* Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and lifecycle management across Benelux and Nordic markets.



* Ensure compliance with country‑specific regulatory requirements, EU MDR obligations, applicable standards, and DePuy Synthes quality management system policies and procedures.



* Serve as the primary QARA point of contact for Benelux & Nordics Local Market Support.



* Coordinate regulatory submissions, technical documentation, and responses to health authority inquiries.



* Partner with cross‑functional teams including Quality, Supply Chain, Commercial, Legal, and Global QARA to support business objectives and supply continuity.



* Monitor regulatory and quality requirement changes across Benelux and Nordic markets and assess potential impacts to products, portfolios, and operations.



* Support and participate in regulatory inspections, quality audits, and compliance assessments as required .



* Contribute to continuous improvement initiatives to enhance QARA efficiency, compliance consistency, and inspection re...