Regulatory Affairs Expert for Medical Device Compliance

Vor 2 Tagen


Aubonne VD, Waadt, Schweiz Intuitive Surgical Vollzeit

We are seeking a highly experienced Regulatory Affairs Specialist to join our team at Intuitive Surgical. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our medical devices with EU and global regulations.

The ideal candidate will have a minimum of 8+ years of experience in regulatory affairs within the medical device industry, with significant experience in EU regulations. A Bachelor's or Master's degree in Engineering, Medical Technology, or a related field is highly preferred.

Responsibilities include leading regulatory efforts in New Product Development (NPD) projects and sustaining operations for Business Units, including preparing, coordinating, and maintaining EU Medical Device dossiers, CE Mark submissions, and associated Technical Documentation.

You will act as a lead contact for Notified Bodies, representing the company's regulatory strategies, addressing inquiries, and ensuring compliance with applicable regulations.

We offer a competitive salary of $120,000 - $150,000 per year, depending on experience. This position also comes with opportunities for professional growth and development, as well as a comprehensive benefits package.

If you are a motivated and detail-oriented individual with excellent organizational skills and a strong understanding of EU medical device regulations, we encourage you to apply for this exciting opportunity.



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