Regulatory Affairs Specialist
Vor 7 Tagen
We are seeking a highly skilled Regulatory and Clinical Affairs Specialist to join our team at CASCINATION AG. As a key member of our organization, you will play a critical role in ensuring the development and upkeep of regulatory documentation to ensure compliance with global standards.
- 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 stakeholders 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
- 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
- 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
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.
AdministrativeWe look forward to receiving your application with CV, letter of motivation, diploma (must), and references (optional). For questions, please contact our HR department.
About UsCASCINATION AG 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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