Compliance Specialist working at Freetrade to help meet regulatory requirements and support product development. Engaging with teams across the business and delivering training and reporting solutions.
About the role
- Regulatory Affairs Specialist at DentalMonitoring ensuring compliance for medical devices and managing regulatory strategies. Participating in quality compliance communications and documentation for market approval.
Responsibilities
- Participate in internal and external communications regarding quality and regulatory requirements
- Define regulatory strategies for health software and mobile health applications (SaMD)
- Prepare, submit and follow up on medical device registration dossiers
- Ensure collection, analysis and follow-up of post-market surveillance data
- Define, review and maintain regulatory product labeling
- Maintain continuous regulatory monitoring
Requirements
- Minimum of 4 years' experience in the Medical Devices sector
- Proven experience preparing and submitting technical documentation for CE marking (under MDR/IVDR) and/or for FDA submissions (510(k), De Novo, PMA)
- Engineering degree, Master’s in Regulatory Affairs, or a degree in a medical or scientific field
- Excellent organizational and analytical skills and strong attention to detail
- Full professional proficiency in English and French (minimum C1 level in both languages)
Benefits
- Swile lunch card
- Private health insurance (Alan)
- Free share allocation plan (equity grants)
- Hybrid work possible
- Active employee benefits program (CSE) — e.g., Urban Sports Club, club-employes.com
- Internal company events
- Employee referral bonus
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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