Senior Regulatory Affairs Specialist

vor 1 Woche


Aubonne VD, Waadt, Schweiz Intuitive Surgical Vollzeit
Job Description

The Senior Regulatory Affairs Specialist plays a critical role in ensuring the compliance of Intuitive Surgical's medical devices with EU and global regulations. This position requires a deep understanding of EU medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and Medical Device Regulation (2017/745/EU).

Main Responsibilities:

Lead regulatory efforts in New Product Development (NPD) projects and sustaining operations for Business Units, ensuring compliance with EU regulations.
Collaborate with cross-functional teams to provide expert guidance on regulatory matters, contributing to the success of product launches and ongoing operations.
Manage the preparation, submission, and maintenance of EU Medical Device and geographic-specific registration dossiers, ensuring alignment with business objectives and timely regulatory approvals.

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 knowledge of Global medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and Medical Device Regulation (2017/745/EU).

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 and experience with 510(k) submissions is an advantage.

About Intuitive Surgical

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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