Regulatory Affairs Specialist - Medical Devices - EN

Michael Page (Belgium); Vlaams-Brabant; Hybride; EUR 52 000 - 78 000; Plein temps

Avantages offerts par ce poste

Hybrid working model

International exposure

Onboarding & development opportunities

Career growth in Regulatory Affairs

Résumé du poste

Michael Page is seeking a Regulatory Affairs Specialist for Medical Devices (EN) to coordinate international registrations, prepare regulatory submissions, and maintain lifecycle compliance. The role involves liaising with manufacturers, distributors, and authorities, and ensuring alignment with MDR requirements.

The successful candidate will have 1–3 years in regulatory affairs for medical devices, strong English communication, and a proactive, internationally collaborative mindset.

Qualifications

• Bachelor's degree or higher in Life Sciences, Biomedical Sciences, Pharmacy or related field.
• 1–3 years of regulatory affairs experience in medical devices.
• Strong knowledge of MDR requirements and registration processes.
• Experience supporting product registrations and lifecycle activities.
• Excellent communication and stakeholder management skills.

Responsabilités

• Coordinate product registrations across assigned international markets.
• Prepare and submit regulatory documentation with internal and external stakeholders.
• Support ongoing compliance activities for medical device portfolios.
• Manage regulatory aspects of product changes throughout the lifecycle.
• Review and assess regulatory implications of marketing materials.
• Monitor regulatory developments and communicate relevant updates.
• Act as a key contact for manufacturers, distributors, and authorities.
• Contribute to continuous improvement initiatives within Regulatory Affairs.

Connaissances

Regulatory affairs

MDR knowledge

Stakeholder management

Communication

Analytical skills

Teamwork

Proactive mindset

Fluent in English

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

About Our Client

International healthcare organization active in the medical device sector, supporting patient care through innovative products distributed across multiple global markets.

Job Description

As a successful Regulatory Affairs Specialist - Medical Devices - EN, you will have the following responsibilities:

• Coordinate product registrations across assigned international markets
• Prepare and submit regulatory documentation with internal and external stakeholders
• Support ongoing compliance activities for medical device portfolios
• Manage regulatory aspects of product changes throughout the lifecycle
• Review and assess regulatory implications of marketing materials
• Monitor regulatory developments and communicate relevant updates
• Act as a key contact for manufacturers, distributors, and authorities
• Contribute to continuous improvement initiatives within Regulatory Affairs

The Successful Applicant

As a successful Regulatory Affairs Specialist - Medical Devices - EN, you will have the following profile:

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or related field
• 1-3 years of experience in Regulatory Affairs within medical devices
• Strong knowledge of MDR requirements and registration processes
• Experience supporting product registrations and lifecycle activities
• Excellent communication and stakeholder management skills
• Proactive personality who actively seeks information and drives actions forward
• Comfortable collaborating with international stakeholders
• Fluent in English
• Strong analytical and organizational skills
• Team-oriented with a continuous improvement mindset

What's on Offer

As a successful Regulatory Affairs Specialist - Medical Devices - EN, you will have:

• Competitive salary package including extra-legal benefits
• Hybrid working model
• International exposure within a global healthcare environment
• Strong onboarding and development opportunities
• Collaborative culture with close interaction between Regulatory Affairs, Quality, and Clinical teams
• Opportunity to build a long-term career in Regulatory Affairs