Freelance Regulatory Affairs Specialist – Medical Devices
Belgium (2 Days Onsite per Week)
3-Month Contract with possible extension
Full-Time – 40 Hours per Week
International Medical Device Markets (Europe, Middle East & Asia)
A growing medical device company based in Belgium is seeking an experienced Freelance Regulatory Affairs Specialist to support ongoing regulatory and compliance activities across international markets.
This is an excellent opportunity for a hands-on RA professional with strong medical device industry experience and proven expertise in EU MDR compliance, technical documentation, and international market registrations.
Key Responsibilities
* Prepare, review, and maintain Technical Documentation and Technical Files in line with EU MDR requirements
* Support and manage regulatory activities for international markets across:
* Europe
* Middle East
* Asia
* Act as or support the Person Responsible for Regulatory Compliance (PRRC)
* Ensure compliance with applicable medical device regulations and standards
* Support product registrations, renewals, and regulatory submissions in global markets
* Collaborate with cross-functional teams including QA/RA, Clinical, R&D, Manufacturing, and Supply Chain
* Support regulatory strategy and market access activities for new and existing products
* Maintain regulatory documentation and ensure ongoing compliance within the Quality Management System (QMS)
* Support interactions with Notified Bodies and international regulatory authorities
* Participate in internal and external audits as required
* Contribute to continuous improvement initiatives across regulatory and quality processes
Requirements
* 3+ years of hands-on Regulatory Affairs experience within the medical device industry
* Strong working knowledge of:
* EU MDR
* Technical Documentation / Technical Files
* International product registrations
* Regulatory compliance activities
* Experience working with international medical device markets including:
* Europe
* Middle East
* Asia
* Experience supporting regulatory activities within the Chinese medical device market is highly desirable
* PRRC experience or eligibility highly preferred
* Strong understanding of regulated medical device environments and applicable international standards
* Experience working with Notified Bodies and regulatory authorities
* Excellent communication and stakeholder management skills
* Fluent English required
Contract Details
* Freelance / Contractor position
* 3-month initial contract- with possible extension
* 40 hours per week
* Hybrid working model:
* 2 days per week onsite in Belgium
* Remaining days remote
Nice to Have
* Experience with CE marking activities
* Knowledge of global regulatory pathways and submissions
* Exposure to post-market surveillance and vigilance activities
* Experience supporting Class II and/or Class III medical devices
* ISO 13485 knowledge or certification
We look forward to hearing from you!