Regulatory Affairs Manager

Vor 3 Tagen

Bern, Schweiz Sigma Vollzeit

I’m currently searching for a Regulatory Affairs Manager for one of my clients, a company specializing in the development and distribution of medical devices on a global scale.

**Main responsibilities**:
Maintain Technical documentation of all products.
Registration of new products.
Keeping up to date with changes in regulatory legislation and guidelines.
Responsibility for all vigilance duties to current regulations.
Review and update of all products related printing materials.
Define regulatory strategy and requirements in support to new product.
Deputy to the responsible for regulatory compliance according art.15 MDR

**Qualifications**:
Technical or scientific degree
Professional experience in regulatory affairs
Experience with approvals under MDR and preparation of technical documentation
Good knowledge of standard ISO 13485
Fluent in English and French

**We offer**:
A diverse job with exciting challenges.
Training in the area of regulatory.
A high degree of personal responsibility.

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