Head of Regulatory Affairs

vor 1 Woche

Zurich, Schweiz Proclinical Vollzeit

**Responsibilities**:

- Handle integrated quality systems with ISO 13485/9001/14001/45001/17025, as well as ISO 50001 would be advantageous.
- You will manage EU IVDR roll out in a global analytical instrumentation corporation - from approval process to daily improvements and managing audits.
- Guide and develop a team of around 20 professionals within 3 countries for QA, Regulatory Affairs and Environment, Health & Safety.
- Guarantee global product compliance in a pro-active and rational manner.

**Skills & Requirements**:

- Educated to a degree level in a pertinent discipline.
- Several years of experience within a medical device organisation such as an MD or IVD within a field of quality and/or regulatory affairs.
- Leadership abilities, globally as week as cross-country.
- Fluency in the English language with knowledge in German and/or French.
- Presentation and training capabilities.
- Communication skills both verbally and in writing towards a varied audience.
- Able to prioritise workload.
- Capable of managing various project simultaneously within a fast-paced setting.
- Willing to travel for business needs.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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