Senior Regulatory Affairs Manager (m/f/d)
Solothurnerstrasse 235, Switzerland | Olten | Full-time
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
Benefits
Corporate Benefits
Benefit from special conditions with various brands in fashion, technology, leisure and many more.
Verpflegung
Je nach Standort gibt es bei uns frisches Obst, knusprige Snacks oder ein kleines Frühstück. Entweder haben wir eine Kantine im Gebäude oder bieten Verpflegungszuschüsse an. So bleiben Sie auch während der Pausen gesättigt und können voll durchstarten.
Gesundheits- und Vorsorgemanagement
Ihre Gesundheit und Ihr Wohlbefinden liegen uns am Herzen. Profitieren Sie daher von unseren vielfältigen Gesundheitsangeboten wie dem Betriebsarzt, der Gesundheitsvorsorge, jährlichen Check-ups, Fitnessangeboten, Stressprävention.
Fort- und Weiterbildungsangebote
Unser Fokus liegt auf der stetigen Weiterentwicklung unserer Mitarbeiter. Wir möchten sicherstellen, dass jeder Einzelne sein volles Potenzial ausschöpfen kann, und bieten daher passgenaue Trainingsangebote für unterschiedliche Positionen an. So verhelfen wir unseren Mitarbeitern zu maximaler Leistung und beflügeln ihren beruflichen Erfolg!
Mobile working
Unsere Mitarbeiter haben die Freiheit, ihre Arbeit zu verrichten, wo immer sie möchten. Mit unseren mobilen Arbeitsplatz-Optionen, Workation-Möglichkeiten und Home-Office-Lösungen können sie von jedem beliebigen Ort aus arbeiten. Volle Flexibilität ist bei uns Programm!
Working environment
Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).
Hinweis: Benefits können je nach Position variieren.