Regulatory Affairs Specialist
Company: Connect Life Science
- Location: Flemish Region, Belgium
- Work mode: Hybrid
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Regulatory Affairs Specialist – Medical Devices
Belgium
Permanent - Full Time
Hybrid Work - 3 days in office near Brussels
Competitive Salary + Package
Connect Life Science is partnering with a global medical device company to recruit a Regulatory Affairs Specialist for its European team.
This role offers broad international exposure, supporting market access and lifecycle management across a portfolio of medical devices and in vitro diagnostics. You’ll take ownership of registration activities across assigned territories, working closely with legal manufacturers, distributors and internal stakeholders.
The role
- Coordinate national registrations, preparing dossiers and managing submission timelines.
- Liaise with competent authorities, manufacturers and distributors to secure and maintain market authorisations.
- Assess product changes and coordinate the regulatory actions required.
- Review marketing materials and claims for regulatory compliance.
- Monitor regulatory developments and advise internal teams on their impact.
- Support improvements to regulatory processes and documentation.
Your background
- Regulatory Affairs experience within class 2 or 3 medical devices (2-5 years)
- Experience preparing registration dossiers and supporting product lifecycle management.
- Knowledge of applicable EU medical device regulations and economic operator obligations.
- Confidence working with manufacturers, distributors and cross-functional teams.
- Strong attention to detail and the ability to manage multiple registration projects.
- MDR experience and working knoweldge
Interested?
Apply with your CV or contact David Clifton at Connect Life Science for a confidential discussion.
