Regulatory Affairs Manager

Vor 3 Tagen

Olten, Schweiz Gerresheimer Vollzeit

Unternehmensbeschreibung

As a listed MDAX company, Gerresheimer is a leading global partner to the healthcare and cosmetics industries. We generate sales of around 1.4 billion euros and are represented worldwide with about 10,000 employees.

Sensile Medical, part of the Gerresheimer Group, is a dynamic company specialized in the development of wearable medical devices for liquid drug delivery. We work daily to improve the quality of life of patients worldwide.

Stellenbeschreibung
- Accompanying development projects from the feasibility phase to the timely approval of products in international markets
- Preparation of regulatory strategies for the approval of products in different markets
- Collaboration with the disciplines R&D, Product Management, Medical Affairs, Industrialization and Quality
- Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles
- Collaboration with regulatory partners at customers and suppliers, authorities and conformity assessment bodies
- Registration of products worldwide; recertifications of products
- Approval of products worldwide; recertification of products
- Assessment, documentation and communication of changes to authorities and conformity assessment bodies
- Representation of regulatory requirements in the company (MDR, US and global requirements)
- Supporting further development of regulatory processes in the quality management system

Qualifikationen
- Successfully completed scientific or engineering studies (or comparable education)
- Profound experience and knowledge in Regulatory Affairs for medical devices (drug-delivery devices, active and connected medical devices would be an advantage)
- More than 3 years' experience in the approval of products in the US, Canada and EU (further markets desirable)
- Pleasure in goal-oriented writing and reviewing of documents
- Systematic, quality-oriented and well-documented working method
- Team player with strong analytical skills who is proactive and solution-oriented
- Dedication and excellent communication skills
- Fluency in German and English

Zusätzliche Informationen

We offer a challenging, international environment and the opportunity to actively contribute to the company and different teams with knowledge and engagement, and to develop personally. We also offer a modern workplace in a historic building, advanced and flexible working conditions as well as salaries according to performance and well-developed social benefits.

**Your contact person - **For further information please contact Mr. Alen Behric, HR Generalist,
+41 62 209 71 00

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