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Regulatory Affairs Manager (Digital Products)
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Location
Burgdorf
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Salary
Negotiable
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Discipline
Regulatory
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Reference
PR/424954_1684397131
The company
- The Regulatory Affairs manager will be based in Burgdorf and have the opportunity to support the company with the production and development of cutting edge medical technology.
Your main tasks
- Manage regulatory responsibilities associated with the development, support and deployment of non-medical and medical device software products within the business area delivery systems
- Manage the development and implementation of regulatory strategies
- Support and prepare product submission documents with main focus on USA, Canada and EU
- Partner with business stakeholders on different levels
- Support life-cycle management activities
- Review quality agreements with customers on regulatory aspects
- Cooperation in QMS ISO 13485 and 21 CFR 820 audits
- General QM tasks (Creation of Q-documents, trainings etc.)
Your profile
- University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
- At least 2 years of professional experience in Regulatory Affairs with focus medical device
- Expertise in Software as a Medical Device (SaMD), digital health related regulations and guidance documents in U.S., Europe, Canada
- Working knowledge of software and software development preferred
- Excellent organisational and people skills
- Good German knowledge (Level B1 or B2)
- Very good English knowledge (Level C2 or MT)