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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Diegem, Flemish Brabant, Belgium
Job Description:
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.
DePuy Synthes is recruiting for a Manager, QARA Benelux & Nordics located in Diegem Belgium
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.
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 by 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.
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**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
The anticipated base pay range for this position is:
€82,000.00 - €141,450.00
Benefits:
In addition to base pay, we offer the following 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. Moreover, we 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. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.