Regulatory Affairs Manager

vor 2 Wochen

Solothurn, Schweiz Ypsomed Vollzeit

Given our dynamic business environment and continued success, we are looking for qualified talent to meet our growing demand and further strengthen our competitive position.

**Regulatory Affairs Manager | **100%**:
Ref. No. 6448
- Location:

- Solothurn- | HybridHelp us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

**Your main tasks**:

- Support and prepare product registrations with main focus on USA and EU
- Support of development projects with a focus on regulatory aspects
- Evaluation of change requests
- Contract negotiations with customers on regulatory aspects
- Support of customers in regulatory issues and preparation of regulatory documents for medical devices and combination
- products
- Communication and correspondence with authorities
- Cooperation in quality audits
- General QM tasks (Creation of Q-documents, trainings etc.)

**Your profile**:

- PhD degree preferably in Natural Sciences or Medical Sciences
- At least 5 years of professional experience as Regulatory Affairs Manager with focus medical device
- Knowledge of the registration of medical device software
- Strong organizational skills and high efficiency
- Ability to communicate adequately with different stakeholders and on different levels
- Good German knowledge (Level B1 or B2)
- Very good English knowledge (Level C2 or MT)

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