20 beste vacatures voor de functie van regulatory affairs environment in groot bijgaarden (nieuwe medewerkers gezocht)

Regulatory Affairs Manager
Nipro Europe Group Companies —Mechelen
- Management
- Teammanagement
- Communicatieve vaardigheden
Medical Advisor, Cardiovascular (Belgium)
Abacus Medicine Group —Anderlecht
- Thuiswerk
- Geneeskunde
- Doctoraat
- Master
13 dagen
Regulatory Affairs Manager
Nipro —Mechelen
- Management
- Teammanagement
- Communicatieve vaardigheden
Drug Safety Advisor
Qplus consult —Melsbroek
- Doctoraat
- Master
Quality Specialist
Hologic —Zaventem
- € 50.000 - € 70.000 per jaar
- ERP systemen
- Microsoft Office
- Bachelor
Project Manager Generalist | Life Science
Capgemini —Diegem
- PMP
- Projectmanagement
Graduate Intern, Financial Services Public Affairs Consultancy, 6-month paid internship
FleishmanHillard —Brussel
- Voltijds
- Financiële diensten
- Stage
- Taalopleiding voorzien
Health & Safety Adviser
IMA Europe —Brussel
- Voltijds
- Spaans
- Engels
- Ter plaatse
- GSM-vergoeding
- Pensioensparen
Snel solliciteren
8 dagen
Sr Manager EMEA Advocacy & Regulatory Intelligence
Ansell —Brussel
- Voltijds
- ICT
- Communicatieve vaardigheden
- Onderhandelen
6 dagen
Head of Regulatory Affairs
Allianz —Brussel
- Voltijds
- Doctoraat
- Engels
- Financiën
Project Manager Generalist | Life Science
Capgemini Sogeti —Diegem
- PMP
- Projectmanagement
Site Conformance Expert | Life Science
Capgemini Sogeti —Diegem
- € 50.000 per jaar
- Master
- Communicatieve vaardigheden
12 dagen
Site Conformance Expert | Life Science
Capgemini —Diegem
- € 50.000 per jaar
- Master
- Communicatieve vaardigheden
12 dagen
Associate Consultant, Tech Policy
APCO Worldwide —Brussel
- Schrijfvaardigheden
- Projectmanagement
- Artificiële intelligentie
Director, International Policy Research and Economics
Bristol-Myers Squibb —Eigenbrakel
- Voltijds
- Hybride werken
- Microsoft Excel
- Onderzoek
- Ter plaatse
Senior Manager EU Affairs
International Air Transport Association (IATA) —Brussel
- Hybride werken
- Analytisch vermogen
6 dagen
Public Policy Manager (all genders) in Brussels
Ridedott —Brussel
- € 50.000 - € 70.000 per jaar
- Voltijds
- Thuiswerk
- Master
- Projectmanagement
- Onderhandelen
(Senior) Managing Director - Public Affairs
Burson Global —Brussel
- Hybride werken
- Microsoft Excel
- Engels
- Artificiële intelligentie
Director, EU Public Affairs
Bavarian Nordic —Brussel
- Voltijds
- Verhuiskostenvergoeding
9 dagen
Research Executive
Rud Pedersen Public Affairs Company AB —Brussel
- Stage
1 dag

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van regulatory affairs environment in groot bijgaarden

Door in te loggen op je account, ga je akkoord met de Algemene voorwaarden van SimplyHired en stem je in met ons Cookie- en privacybeleid.

Zoek vacatures in meer locaties

regulatory affairs environment jobs near groot bijgaarden

Vacatures voor een Regulatory Affairs Manager in Mechelen

Vacatures voor een Regulatory Affairs Specialist in Brussel

Vacatures voor een Stage Data Science in Brussels

Vacatures voor een Recruitment Consultant in Bruxelles

Vacatures voor een Regulatory Affairs Manager in Zaventem

Vacatures voor een Hotel Manager in Brussels

Vacatures voor een Project Manager in Hasselt België

Vacatures voor een Quality Specialist in Braine L'alleud

Vacatures voor een Advocacy Manager in Bruxelles Capitale

Vacatures voor een Cafe Manager in Brussel

Vacatures voor een Public Health in Bruxelles

Vacatures voor een Eu Government Affairs in Bruxelles

Vacatures voor een Senior Designer in Bruxelles

Vacatures voor een Senior Product Manager in Antwerpen

Vacatures voor een Junior Researcher in Bruxelles

Vacatures voor een Researcher in Brussel

Vacatures voor een Manager in Kortrijk

Vacatures voor een Manager Leidinggevende Functie in Limburg (provincie)

Vacatures voor een Paid Intern in Brussels

Vacatures voor een Translation Intern in Bruxelles

Regulatory Affairs Manager

Nipro Europe Group Companies -
Mechelen

Nu solliciteren

Vacaturegegevens

Kwalificaties

Management
Projectcoördinatie
Teammanagement
Communicatieve vaardigheden

Volledige vacaturetekst

About the company

We are looking for a Regulatory Affairs Manager who is experienced, hands-on, and communicative to join us in our Regulatory Affairs team, based in our EMEA headquarters office in Mechelen, Belgium.

About the role

As Regulatory Affairs Manager, you will ensure that Nipro Medical Europe (NME) meets its regulatory obligations under the EU Medical Device Regulation (MDR). A key part of your role will be leading, developing, and coordinating your team to deliver high-quality regulatory outputs. You will oversee registrations, maintain RA compliance, interpret regulatory intelligence, and provide strategic direction to your team. Through strong people management and clear prioritization, you will safeguard business continuity while ensuring Nipro fulfils its responsibilities as importer, distributor, and authorized representative (excluding vigilance and PMS).

How you will contribute

Registration / RA Compliance – 40%

Track and document local registration requirements and timelines.
Assign and execute registration projects in line with procedures, work instructions, and agreed timelines.
Report high-level registration status.
Coordinate projects impacting local market access.
Communicate updates in distributor, importer, exporter, and authorized representative activities to Belgian Competent Authorities in due time.
Support tenders related to regulatory topics.
Continuously improve registration processes and procedures to strengthen collaboration and communication across NME departments.

Regulatory Intelligence – 15%

Scan the regulatory landscape for changes and new applicable legislation.
Interpret regulatory changes and assess impact for Nipro.
Create action plans and organize compliance initiatives within the organization.

MDR Compliance – 15%

Maintain the certificate library (EC certificates, Declarations of Conformity, ISO 13485 certificates).
Ensure NME has access to technical files for which it is appointed as authorized representative.
Provide non-product-related regulatory support to internal and external stakeholders.
Escalate non-compliances to the Person Responsible for Regulatory Compliance.
Review quality agreements accompanying distribution agreements.

Team Management – 20%

Build knowledge, proactivity, and team spirit within the RA team to ensure they are a trusted partner in the organization.
Fulfil all people management responsibilities for the RA team (1 team, 3 team members).

Change Process (PVNC/VNC) – 5%

Review changes initiated by local markets or suppliers and support improvements to change management processes.

Marketing RA Approval & Quality Specification Review – 5%

Conduct regulatory approval of marketing materials (MAF).
Perform regulatory review of quality specifications and draft procedural documentation for this process.

What you bring to Nipro

Leadership mindset with the ability to grow and guide a team.
Experience in Regulatory Affairs, ideally in medical devices, pharmaceuticals, or another regulated industry.
Strong understanding of EU MDR and Economic Operator responsibilities.
Excellent planning, prioritization, and project coordination skills.
Hands-on, proactive, and solution-oriented mindset.
Strong communication skills and ability to work cross-functionally and internationally.
High attention to detail and strong analytical capability.
Ability to work independently while fostering effective teamwork.

Preferred Skills

Experience managing or coaching small teams.
Experience interacting with Competent Authorities.
Experience with regulatory workflows, tools, and documentation systems.
Familiarity with tender processes related to regulatory topics.
Fluency in English; additional European languages are an asset.

Why you should apply

You want to contribute to a purpose-driven organization that improves patient outcomes worldwide.
You value a respectful, inclusive, and collaborative working environment.
You enjoy roles that combine structure, autonomy, improvement mindset, and leadership.
You want to grow your career in an international environment where your expertise has clear impact.

NIPRO delivers on its purpose to help all people Live Longer. Live Better.

Our purpose is grounded in care, respect, and a deep commitment to the well-being of every life we touch—patients, partners, and team members. We believe that every colleague at NIPRO plays a vital role in our mission: to push innovation forward, improve patient outcomes, and make world-class healthcare accessible to all.

Respect is active and essential at NIPRO - it is our way of working, thinking, and growing together. We promote an environment where people feel safe to contribute, constructive ideas flow freely, and every person is treated with dignity.

Nu solliciteren

Verfijn je zoekopdracht

regulatory affairs environment vacatures in groot bijgaarden

Regulatory Affairs Manager

Medical Advisor, Cardiovascular (Belgium)

Regulatory Affairs Manager

Drug Safety Advisor

Quality Specialist

Project Manager Generalist | Life Science

Graduate Intern, Financial Services Public Affairs Consultancy, 6-month paid internship

Health & Safety Adviser

Sr Manager EMEA Advocacy & Regulatory Intelligence

Head of Regulatory Affairs

Project Manager Generalist | Life Science

Site Conformance Expert | Life Science

Site Conformance Expert | Life Science

Associate Consultant, Tech Policy

Director, International Policy Research and Economics

Senior Manager EU Affairs

Public Policy Manager (all genders) in Brussels

(Senior) Managing Director - Public Affairs

Director, EU Public Affairs

Research Executive

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van regulatory affairs environment in groot bijgaarden

Related Searches

Zoek vacatures in meer locaties

Tools voor werkzoekenden

Werkgeverstools

Bladeren

Blijf verbonden