Senior Regulatory Affairs Manager
vor 1 Woche
Become a part of elemed's journey towards revolutionizing healthcare with innovative medical devices. As a Senior Regulatory Affairs Specialist, you will be at the forefront of ensuring our products meet regulatory requirements, allowing us to bring them to market efficiently.
Senior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | QualityRole: Senior Regulatory Affairs Specialist
This is an exciting opportunity to work with a talented team dedicated to making a difference in people's lives. In this role, you will be responsible for maintaining the CE mark and PMA, managing technical documentation on an international scale, and acting as the point of contact with notified bodies and health authorities. You will also collaborate 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.
The Opportunity
We are seeking a highly skilled candidate with 3+ years of Regulatory Affairs experience in the medical device industry. A key understanding of IEC 60601-1 is essential, along with experience in CE marking. Excellent communication skills in English are required. If you are passionate about regulatory affairs and want to contribute to the success of our company, please send your CV to arrange a confidential career discussion.
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