Medical Device Regulatory Specialist

Michael Page; Vlaams-Brabant; Sur place; EUR 42 000 - 68 000; Plein temps

Avantages offerts par ce poste

Permanent contract

Attractive benefits

International exposure

Structured onboarding

Long-term career development

Résumé du poste

Michael Page is partnering with an international healthcare organisation in the medical device sector to recruit a Regulatory Affairs Specialist. You will coordinate registrations across markets, manage regulatory documentation, and liaise with internal teams and external authorities.

The successful candidate will have 1–3 years in Regulatory Affairs for medical devices, strong MDR knowledge, and excellent English communication and analytical skills.

Qualifications

• Bachelor's or master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related field.
• Between 1 and 3 years of Regulatory Affairs experience within medical devices.
• Good knowledge of MDR, product registrations and regulatory documentation.
• Proactive and organised, with strong analytical and communication skills.
• Comfortable working with international teams and different stakeholders.
• Fluent in English.

Responsabilités

• Coordinate medical device registrations across assigned international markets.
• Prepare, review and submit regulatory documentation with internal and external stakeholders.
• Support regulatory compliance and manage changes throughout the product lifecycle.
• Review marketing materials and assess their regulatory implications.
• Monitor regulatory developments and communicate relevant updates internally; Act as a contact for manufacturers, distributors and competent authorities.

Connaissances

Regulatory affairs

Regulatory MDR knowledge

English fluency

Stakeholder communication

Analytical skills

Team collaboration

Formation

Bachelor's or Master's in Life Sciences or Regulatory Affairs

Description du poste

• Regulatory Affairs, Medical Devices, MDR, EU MDR, Product Registration
• Product Lifecycle Management, Change Control, Regulatory Intelligence

About Our Client

Our client is an international healthcare organisation active in the medical device industry. The company develops and distributes products that support healthcare professionals and patient care across several international markets.

To strengthen its Regulatory Affairs team, the organisation is looking for a Regulatory Affairs Specialist who will work closely with Quality, Clinical Affairs and other international stakeholders.

Job Description

As a Regulatory Affairs Specialist, Medical Devices your responsibilities are:

• Coordinate medical device registrations across assigned international markets
• Prepare, review and submit regulatory documentation with internal and external stakeholders
• Support regulatory compliance and manage changes throughout the product lifecycle
• Review marketing materials and assess their regulatory implications
• Monitor regulatory developments and communicate relevant updates internallyAct as a contact for manufacturers, distributors and competent authorities

The Successful Applicant

A successful 'Regulatory Affairs Specialist, Medical Devices' should have:

• Bachelor's or master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related field
• Between 1 and 3 years of Regulatory Affairs experience within medical devices
• Good knowledge of MDR, product registrations and regulatory documentation
• Proactive and organised, with strong analytical and communication skills
• Comfortable working with international teams and different stakeholders
• Fluent in English

What's On Offer

Our customer offers you:

• A permanent contract with a competitive salary package
• Attractive extra-legal benefits
• International exposure within the medical device industry
• Structured onboarding and development opportunities
• The possibility to build a long-term career in Regulatory Affairs