Regulatory and Clinical Affairs Specialist

Your mission

Your Mission : You will be responsible for the development and upkeep of 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
• Liaise with Research & Development to create and maintain technical files
• Liaise with notified bodies, health authorities, and other relevant stake holders on behalf of the organization
• Monitor regulatory changes and ensure products adhere to evolving requirements
• Ensure alignment of departmental objectives and integration of regulatory requirements into product development through direct interdepartmental communication
• Conducting literature reviews and clinical evaluations

Your profile

You are

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%

About us

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.