Senior Regulatory Affairs Specialist

vor 1 Monat

Aubonne VD, Waadt, Schweiz Intuitive Surgical Vollzeit
Company Overview

At Intuitive Surgical, we are driven by a shared vision to revolutionize minimally invasive care. Our team of innovators and experts is united behind a mission to empower physicians to heal without constraints. Through cutting-edge technology and a commitment to excellence, we strive to make a meaningful impact on the lives of patients and healthcare professionals worldwide.

Job Summary

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Regulatory Affairs Department. As a key member of our team, you will play a critical role in ensuring the compliance of our medical devices with EU regulations. Your expertise will be instrumental in guiding cross-functional teams and contributing to the success of product launches and ongoing operations.

Key Responsibilities
  • Lead regulatory efforts in New Product Development (NPD) projects and sustaining operations, ensuring compliance with EU regulations and directives.
  • Collaborate with cross-functional teams to provide expert guidance on regulatory matters, including CE Mark submissions and interactions with Notified Bodies.
  • Manage the preparation, submission, and maintenance of EU Medical Device and geographic-specific registration dossiers, ensuring alignment with business objectives and timely regulatory approvals.
  • Develop and implement EU regulatory strategies for new product introductions, product changes, and new indications, ensuring alignment with business goals.
  • 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 to maintain compliance.
  • Coordinate registration strategy with Sales and Marketing stakeholders, aligning regulatory requirements with business objectives.
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, though practical experience in a similar role will be considered.
  • 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.
  • Strong organizational, leadership, and interpersonal skills, with a proactive approach to problem-solving, a sense of urgency, and the ability to collaborate effectively within international teams and across departments.
  • A meticulous attention to detail, ensuring accuracy and completeness in all work-related tasks.
  • Knowledge of EU regulations and directives relevant to product compliance, such as RED, ROHS, and the Waste Framework Directive.
  • Proficiency in English, with a minimum of C1 level proficiency in both written and spoken forms.
  • General computer proficiency, including Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook.
Preferred Qualifications
  • Exposure to Class III medical device submissions under the EU Medical Device Regulation, particularly for CE Marking, is desirable.
  • Experience in project management or leading cross-functional teams in regulatory affairs or product development contexts.
  • Familiarity with US FDA regulations (21 CFR 820.30) and experience with 510(k) submissions is an advantage.
Additional Information

Intuitive Surgical is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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