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%
CASCINATION is a Swiss medical device company with a mission to bring certainty to medical treatment outcomes. Our robotic and image-guided solutions enable clinicians to perform reproducible and efficient interventions, that deliver quality outcomes from minimally invasive therapies across a range of disciplines from cancer treatment to the treatment of hearing disorders.
Wir freuen uns über Ihr Interesse an CASCINATION AG. Bitte füllen Sie das folgende kurze Formular aus. Sollten Sie Schwierigkeiten mit dem Upload Ihrer Daten haben, wende Sie sich gerne per Email an jobs@cascination.com.
