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
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 proactive problem-solver who drives projects forward
Strong team player with excellent communication skills, capable of effectively collaborating with cross-functional teams
A highly analytical, detailed-oriented, and independent personality who develops effective and practical solutions and strategies
Open, flexible, and highly motivated to work in a dynamic environment
Pragmatic and creative in developing solutions
Intellectually curious, adaptable, and a fast learner with an open mind
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.
We appreciate your interest in our company CASCINATION AG. Please fill in the following short form. Should you have any difficulties in uploading your files, please contact us by mail at jobs@cascination.com
