Your mission
Your Mission: You will take ownership in the development of regulatory strategies, submissions, and regulatory documentation to ensure compliance with global standards. Key tasks include:
- Develop and execute regulatory strategies aligned with business objectives
- Create, submit, and maintain regulatory documentation, including technical files and submissions required for compliance, in liaison with Research & Development
- Liaise with notified bodies, health authorities, and other relevant stake holders on behalf of the organization
- Monitor and interpret regulatory changes and ensure products adhere to evolving requirements
- Integrate regulatory requirements into product development through cross-functional collaboration
- Conduct literature reviews and clinical evaluations
Your profile
- Educational background in Engineering
- Minimum of 2 years of experience in Regulatory Affairs in the field of surgical navigation and/or robotics
- Strong understanding of the European and U.S. medical device regulations (knowledge of additional global regulations is a plus)
- Exceptional English writing skills—clear, structured, and concise
- Proficient in MS Word and other information management tools
You are
- A reliable, proactive professional who delivers on commitments and takes ownership
- A confident and strong communicator capable of effectively collaborating and building trust with internal teams and external authorities
- A highly analytical, detail-oriented, and solution-focused person who drives projects forward with practical solutions
- Pragmatic and creative in developing solutions
- Intellectually curious, flexible, a fast learner with an open mind, and highly motivated to work in a dynamic environment
Why us?
We offer a challenging role in a multinational, innovative, fast-growing, and dynamic environment. In our company you can create, shape, and take on responsibility. Our unique company culture is shaped by our passion and values.
Administrative
We look forward to receiving your application with CV, letter of motivation, diploma (must), and references (optional). (Applications from recruiters will not be considered). For questions, please contact Mr. Augustin Blazevic (+41 31 306 26 05).
Place of work: Bern
Preferred start date: by agreement
Workload: 100%