Regulatory and Clinical Affairs Specialist

Vor 2 Tagen

Bern, Schweiz CASCINATION AG Vollzeit
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

  • Educational background in Engineering
  • Minimum of 3-4 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%

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.

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