Manager, QARA Benelux & Nordics

7260-Johnson & Johnson Medical B.V. Legal Entity; Amersfoort; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Manager, QARA Benelux & Nordics, located in Amersfoort, Netherlands. This role leads Quality Assurance and Regulatory Affairs operations across Benelux and Nordic markets to ensure regulatory compliance and sustained market access for DePuy Synthes Orthopedics within a highly regulated European framework.

You will partner with local market teams and global QARA colleagues to manage risk, lifecycle activities, and cross‑functional governance, while ensuring patient

Qualifications

• Education: bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering or related field.
• Advanced degree or professional certification preferred in Regulatory Affairs or Quality.
• 6–8 years of QA/Regulatory Affairs experience in medical devices or healthcare.

Responsibilities

• Lead QA and regulatory activities to support registrations, renewals, variations and lifecycle management across Benelux and Nordics.
• Ensure EU MDR compliance and QMS adherence across markets.
• Act as primary QARA contact for Benelux & Nordics Local Market Support.
• Coordinate regulatory submissions, technical documentation, and health authority responses.
• Collaborate with Quality, Supply Chain, Commercial, Legal and Global QARA teams to support objectives.
• Monitor regulatory changes and assess impacts on products and operations.
• Support regulatory inspections, audits and compliance assessments.
• Contribute to continuous improvement of QARA processes and inspection readiness.
• Engage in regional policy initiatives critical to business growth.

Skills

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Fact‑Based Decision Making

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related

Advanced degree or professional certification in Regulatory Affairs, Quality, or related field

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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. The 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.

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• we also offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

The anticipated base pay range for this position is: €68,600.00 - €119,600.00

Required Skills: Preferred Skills:

• Analytical Reasoning
• Business Writing
• Coaching
• Compliance Risk
• Fact-Based Decision Making
• Industry Analysis
• Legal Support
• Process Improvements
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Strategic Thinking
• Technical Credibility

Additional information

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 orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson &Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected under federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson &Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

At Johnson &Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.