Manager, QARA Benelux & Nordics
Johnson & Johnson MedTech · Amersfoort, Utrecht, Netherlands
2 dagen geleden geplaatst
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Functie:
Regulatory Affairs GroupSubfunctie functie:
Regulatory AffairsFunctiecategorie:
ProfessionalAlle vacaturelocaties:
Amersfoort, Utrecht, NetherlandsFunctieomschrijving:Functieomschrijving:
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.
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 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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Vereiste vaardigheden:
Gewenste vaardigheden:
Analytisch redeneren, Beheer van regelgevingszaken, Coachen, Industrie-analyse, Juridische ondersteuning, Ontwikkeling van wetgeving, Op feiten gebaseerde besluitvorming, Overheidsbeleid, Procesverbeteringen, Productlicentiëring, Regelgevingsklimaat, Regulatorische compliance, Risicobeoordelingen, Risicocompliance, Strategisch denken, Technische geloofwaardigheid, Zakelijk schrijven
Het te verwachten bruto jaarsalaris voor deze functie ligt tussen de:
€68,600.00 - €119,600.00
Voordelen:
Naast het basissalaris bieden wij de volgende benefits*: Een jaarlijkse bonus met een vast percentage (% van het salaris) afhankelijk van de salarisschaal / land, waarbij het werkelijke bedrag is gebaseerd op de prestaties van de werknemer en de onderneming in het voorgaande kalenderjaar, of verkoopcommissies. Bovendien bieden wij vakantiedagen, minimaal 12 weken ouderschapsverlof, verlof bij overlijden van directe familie, zorgverlof, vrijwilligersverlof en welzijns programma's voor financiële, fysieke en geestelijke gezondheid. We bieden ook jubileum- en erkenningsbeloningen aan en afhankelijk van de voorwaarden van hun respectieve plannen, kunnen medewerkers - en in sommige locaties hun aanverwanten - deelnemen aan verschillende verzekeringsplannen. Ga voor meer informatie naar Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*dit is alleen voor informatieve doeleinden. Bedragen en werkelijke benefits kunnen per land verschillen en kunnen worden gewijzigd.