Manager, QARA Benelux & Nordics

Johnson Johnson; Amersfoort; On-site; EUR 110,000 - 150,000; Full time

Job summary

Johnson & Johnson in Amersfoort, Netherlands, seeks a Manager of Quality Assurance & Regulatory Affairs (QARA) for Benelux & Nordics to lead regulatory compliance and QMS execution across markets.

You will partner with local teams and global QARA to ensure market access and patient safety, overseeing registrations, lifecycle activities, and regulatory inspections in a highly regulated European environment.

Qualifications

• 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs.
• Strong knowledge of EU MDR requirements across Benelux and Nordic markets.
• Experience managing product registrations and lifecycle activities.
• Ability to interpret regulatory and quality requirements to support business decisions.
• Strong stakeholder management and communication skills.
• Must be Belgian citizen and have a valid Belgian passport.

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 readiness.
• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Skills

Regulatory affairs

Quality assurance

EU MDR knowledge

Product registrations

Lifecycle management

Stakeholder management

Communication

Education

Bachelor's degree in Regulatory Affairs or Life Sciences

Advanced degree or professional certification

Job description

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 readiness.
• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Qualifications

Education

Required: Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.

Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.

Experience and Skills

Required:

• 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare, or other regulated industries.
• Strong working knowledge of EU MDR requirements and Benelux/Nordic regulatory environments.
• Experience managing product registrations and lifecycle activities across multiple European markets.
• Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
• Strong stakeholder management, communication, and collaboration skills.
• Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment.
• Must be a Belgian citizen and have a valid Belgian passport

Preferred:

• Experience supporting multi‑country QARA portfolios.
• Experience working in multinational or matrixed organizations.
• Exposure to regulatory inspections, quality audits, or health authority interactions.
• Familiarity with EU MDR implementation, post‑market surveillance, and vigilance requirements.
• Demonstrated experience contributing to regulatory or quality process improvement initiatives.
• Regulatory Affairs or Quality certification (e.g., RAC or equivalent).

Other

• Language: English required ; Dutch and/or French preferred.
• Travel: Limited; occasional regional travel within Benelux and Nordics.
• Certifications: RAC or equivalent preferred but not required .

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopa