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Regulatory Affairs Manager
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Location
Solothurn
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Salary
Negotiable
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Discipline
Regulatory
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Reference
PR/424954_1684396953
The company
- The Regulatory Affairs manager will be based in Solothurn and have the opportunity to support the company with the production and development of cutting edge medical technology.
Your main tasks
- Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
- Manage the development and implementation of regulatory strategies
- Support and prepare product submission documents with main focus on EU and Canada
- Partner with business stakeholders on different levels
- Support life-cycle management activities
- Communication and correspondence with authorities
- Cooperation in QMS ISO 13485 and 21 CFR 820 audits
- General QM tasks (Creation of Q-documents, training 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 Active Medical Devices related regulations and guidance documents in Europe and Canada
- Excellent organisation and people skills
- Very good English knowledge (Level C2 or MT)
- Good German knowledge (Level B1 or B2)
