Regulatory Affairs Specialist
vor 4 Wochen
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 be responsible for ensuring the development and upkeep of regulatory documentation to guarantee compliance with global standards.
- Develop and execute regulatory strategies aligned with business objectives to drive growth and innovation.
- Create, submit, and maintain regulatory documentation, including technical files and submissions required for compliance, to ensure seamless product launches.
- Liaise with Research & Development to create and maintain technical files, fostering collaboration and driving product development.
- Liaise with notified bodies, health authorities, and other relevant stakeholders on behalf of the organization to ensure regulatory requirements are met.
- Monitor regulatory changes and ensure products adhere to evolving requirements, staying ahead of the curve in a rapidly changing regulatory landscape.
- Ensure alignment of departmental objectives and integration of regulatory requirements into product development through direct interdepartmental communication, promoting a culture of compliance.
- Conducting literature reviews and clinical evaluations to inform regulatory decisions and drive business growth.
- Educational background in Engineering, with a strong foundation in scientific principles and regulatory frameworks.
- Minimum of 2 years of experience in Regulatory Affairs in the field of surgical navigation and/or robotics, with a proven track record of success.
- Strong understanding of the European and U.S. medical device regulations, with knowledge of additional global regulations a plus.
- Exceptional English writing skills—clear, structured, and concise, with the ability to communicate complex regulatory information effectively.
- Proficient in MS Word and other information management tools, with the ability to adapt to new technologies and systems.
CASCINATION AG is a Swiss medical device company dedicated to bringing certainty to medical treatment outcomes. Our robotic and image-guided solutions enable clinicians to perform reproducible and efficient interventions, delivering quality outcomes from minimally invasive therapies across a range of disciplines.
AdministrativeWe look forward to receiving your application with CV, letter of motivation, diploma (must), and references (optional). For questions, please contact our HR department.
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