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Regulatory Affairs Manager
Laborie Medical Technologies Corp
Netherlands · Remote possibleSenior (5–10 years)Full-timePosted 25 days ago
About the job
What you'll do
The Regulatory Affairs Manager will lead international regulatory strategies and manage complex projects for multiple product lines across EMEA and LATAM regions. They are responsible for preparing regulatory dossiers, ensuring compliance with EU MDR, and serving as a primary contact for regulatory authorities and distributors.
What they're looking for
Candidates must hold a bachelor's degree in a relevant scientific or engineering discipline and possess at least 7 years of regulatory experience in the medical device industry. Proficiency in EU MDR (2017/745) and experience with Class II/III medical device registrations are essential requirements.
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