Medical Device Regulatory Specialist

Michael Page (Belgium); Vlaams-Brabant; On-site; EUR 52,000 - 70,000; Full time

Benefits offered by this job

Permanent contract

Salary package

Benefits

Job summary

Michael Page Belgium is seeking a Regulatory Affairs Specialist for the medical devices sector to coordinate registrations across international markets and ensure MDR compliance. You will prepare and submit regulatory documentation, support lifecycle changes, and liaise with manufacturers, distributors and authorities.

The role requires a Life Sciences or regulatory-focused degree, 1–3 years of Regulatory Affairs experience in medical devices, and fluent English.

Qualifications

• Bachelor's or master's degree in Life Sciences or regulatory field.
• 1–3 years of Regulatory Affairs experience in medical devices.
• Good knowledge of MDR and regulatory documentation.
• Proactive, organized, with strong communication skills.
• Experience working with international teams.

Responsibilities

• Coordinate medical device registrations across markets.
• Prepare, review, and submit regulatory documentation with stakeholders.
• Support regulatory compliance and lifecycle changes.
• Review marketing materials for regulatory impact.
• Monitor regulatory developments and communicate updates.
• Act as contact for manufacturers, distributors and authorities.

Skills

Regulatory affairs

MDR knowledge

Product registrations

Lifecycle management

Change control

Regulatory intelligence

Regulatory documentation

Stakeholder communication

English fluent

Education

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

Regulatory affairs related degree or certification

Job description

• 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 internally
• Act 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