Medical Device Compliance Specialist
vor 1 Woche
Take the next step in your career with elemed, a well-established company in Zurich driving innovation in Class III active-implantable medical devices. Our company is committed to developing and producing cutting-edge products that make a real difference in people's lives.
Senior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | QualityRole: Senior Regulatory Affairs Specialist
We are currently seeking a Senior Regulatory Affairs Specialist to join our dynamic team. This is an exciting opportunity to work on a product that has already achieved CE marking and US certification. As part of our QA/RA team, you will play a crucial role in supporting the continuation of the regulatory strategy for our life-changing device.
The Opportunity
In this role, you will have the chance to develop your skills and further advance your career. You will work closely with our VP RA/QA and Director of RA/QA on various aspects of regulatory affairs, including maintenance activities, design control meetings, and advise on development and remediation projects. Your responsibilities will include managing technical documentation on an international scale, maintaining the CE mark and PMA, and acting as the point of contact with notified bodies and health authorities.
Key Requirements:
- 3+ years of Regulatory Affairs experience in the medical device industry
- A key understanding of IEC 60601-1
- Experience in CE marking is a must
- Excellent communication skills in English
If you are a motivated and detail-oriented professional looking for a new challenge, we encourage you to apply. Please send your CV to arrange a confidential career discussion.
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