Senior Regulatory Affairs Manager (m/f/d)

Stellenbeschreibung

• Accompanying development of digital health products, particularly standalone software medical devices, from the feasibility phase to the timely approval of products in international markets
• Close collaboration with the digital team, as well as R&D, Product Management, Medical Affairs and Quality
• Preparation of regulatory strategies for the approval of products in different markets
• Determination applicable registration requirements for standalone software medical devices, in all countries in which the products are to be registered
• Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles
• Review of deliverables from other disciplines
• Preparation of regulatory submission files
• Collaboration with regulatory partners at customers and suppliers, authorities, and conformity assessment bodies
• Approval of products worldwide; recertification of products
• Assessment, documentation, and communication of changes to authorities and conformity assessment bodies
• Representation of regulatory interests 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 connected medical devices and apps (software as a medical device [SaMD]), drug-delivery devices would be an advantage
• Experience in the submission and approval of products in the US, Canada and EU (further markets desirable), particularly for standalone software medical devices
• Knowledge and experience in addressing requirements for Digital Therapeutics (DTx), artificial intelligence/machine learning (AI/ML) and cybersecurity would be an advantage
• 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 English (German would be an advantage)

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.

Interested? Please upload your complete application (letter of motivation, CV, job references, diplomas / certificates) by clicking on the "apply now" button. We look forward to reading from you.

Your contact person - For further information please contact Mr. René Ziegler, Senior Recruiting Specialist, +41 62 209 71 00