Regulatory Affairs Specialist - Medical Devices - EN

Vlaams Brabant Vast dienstverband 64,871€ - 81,089€ per jaar Bekijk de functieomschrijving
Our client is a global healthcare organization active in the medical device sector. To support continued growth and regulatory compliance across international markets, they are looking for a Regulatory Affairs Specialist. This position combines registration activities, lifecycle management, regulatory intelligence, and cross-functional collaboration within a dynamic international environment.

Toegevoegd 13/10/2026

  • Drive medical device registrations across international markets
  • Broad RA exposure beyond dossiers, with strong stakeholder impact

Over onze klant

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

Functie

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

Profiel

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

Aanbod

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
Contact
Morgane Delgeye
Referentienummer
JN-092026-7115820

Vacature samenvatting

Sector
Biowetenschappen
Sub Sector
Regelgeving
Industrie
Healthcare / Pharmaceutical
Locatie
Vlaams Brabant
Contract Type
Vast dienstverband
Consultant naam
Morgane Delgeye
Vacature referentie
JN-092026-7115820

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