Regulatory Affairs Professional
Vor 3 Tagen
Elemed is a well-established company in Zurich, Switzerland, designing and developing innovative Class III active-implantable medical devices. Our products are CE marked and have a significant impact on patients' lives.
Job DescriptionThe Senior Regulatory Affairs Specialist will join our close-knit team to support the expansion of our QA/RA department. As a key member, you will work closely with top experts in their field, developing your skills and advancing your career.
- Manage technical documentation on an international scale
- Maintain the CE mark and PMA
- Act as the point of contact with notified bodies and health authorities
- Support the VP RA/QA and Director of RA/QA with maintenance activities for regulatory affairs
- Lead design control meetings and activities, including creation and maintenance of technical documentation, DHFs, DMRs
- Advise on development and remediation projects from a regulatory perspective
- Support electrical safety and software-related activities
- Evaluate processes and assess the impact on regulatory compliance
- At least 3 years of experience in Regulatory Affairs within the medical device industry
- A deep understanding of IEC 60601-1
- CE marking experience is essential
- Excellent communication skills in English
We offer a dynamic and fast-paced work environment, opportunities for professional growth, and a chance to be part of a team that changes lives.
OthersIf you're interested in exploring this opportunity further, please consider sending your CV to initiate a confidential career discussion.
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