Senior Regulatory Affairs Specialist

vor 3 Wochen

Aubonne VD, Waadt, Schweiz Intuitive Surgical Vollzeit
Company Overview

Intuitive Surgical is a pioneering company in the field of minimally invasive care, committed to expanding the potential of physicians to heal without constraints. Our mission is to advance the world of minimally invasive care through ingenuity and intelligent technology.

Job Summary

We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our Regulatory Affairs Department. This role will play a critical part in providing advanced regulatory support for New Product Development (NPD) and sustaining operations across designated Business Units.

Key Responsibilities
  • Lead regulatory efforts in NPD projects and sustaining operations for Business Units, ensuring compliance with EU regulations.
  • Act as a lead contact for Notified Bodies, representing the company's regulatory strategies and ensuring compliance with applicable regulations.
  • Manage the preparation, submission, and maintenance of EU Medical Device and geographic-specific registration dossiers, ensuring alignment with business objectives.
  • Collaborate in the development and implementation of EU regulatory strategies for new product introductions, product changes, and new indications.
  • Provide regulatory advice to cross-functional teams, ensuring product development and changes are in line with current regulatory requirements.
  • Monitor and communicate changes in Global and EU medical device regulations and standards, updating company policies and procedures as necessary.
Requirements
  • 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.
  • In-depth understanding of Global medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and Medical Device Regulation (2017/745/EU).
  • Proven experience leading EU submissions for NPD projects and sustaining activities, including preparing CE Mark documentation and managing interactions with Notified Bodies.
Preferred Qualifications
  • Exposure to Class III medical device submissions under the EU Medical Device Regulation, particularly for CE Marking.
  • Experience in project management or leading cross-functional teams in regulatory affairs or product development contexts.
What We Offer

Intuitive Surgical is an Equal Employment Opportunity Employer, committed to fostering an inclusive and diverse team. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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