Regulatory Affairs Manager

vor 2 Wochen


Basel, Schweiz CPL Recruitment Vollzeit

**Posted date **15 April 2024

**Location**Basel

**Job type** Permanent

**Salary**Negotiable

**Discipline** Life Sciences

**Reference**JO-2404-533260

**Work Location** Hybrid

An exciting and growing business looking to bring state-of-the-art medical technology to the market, enabling people globally to self-manage diabetes and other chronic diseases, are looking to hire an exceptional Regulatory Affairs Manager, to support particularly their rapidly developing Diabetes Care division (active and connected devices). Based Solothurn - hybrid working.

Key job responsibilities:

- Manage the development and implementation of regulatory strategies
- Support and prepare product submission documents with main focus on EU and US
- Partner with business stakeholders on different levels
- Communication and correspondence with authorities
- Cooperation in QMS ISO 13485 and 21 CFR 820 audits
- General QM tasks (Creation of Q-documents, trainings etc.)
- University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
- At least 4 years of professional experience in Regulatory Affairs with focus medical device
- Expertise in Active Medical Devices related regulations and guidance documents in EU and US
- Excellent organizational and people skills
- Very good English knowledge (Level C2 or MT)

Sarah Goddard



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