Regulatory and Clinical Affairs Specialist
Regulatory and Clinical Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Your mission
- 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 skillsclear 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
Administrative
Place of work: Bern
Preferred start date: by agreement
Workload: 100%
About us
disciplines from cancer treatment to the treatment of hearing disorders.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
