Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.
Job Description
Primary Function of Position:
The Regulatory Affairs Specialist supports the Regulatory Affairs Department on operational activities across EMEA, with a focus on registrations, EUDAMED/Swissdamed implementation, compliance support, and internal stakeholder support. The role helps maintain regulatory compliance through documentation, follow-up, and coordination of assigned RA activities. This role is based on-site in Aubonne, Switzerland.
Roles and Responsibilities:
Main activities
- Support registration activities across EMEA, including CE marking support, non-medical products, and local registrations, as assigned.
- Support EUDAMED and Swissdamed implementation activities, including data collection, data checks, tracker updates, and follow-up with relevant stakeholders.
- Support compliance activities, including CAPA, audit follow-up, inspection readiness, and maintenance of RA documentation.
- Support RA operational activities such as labeling and eIFU, procedures, trackers, dashboards, and continuous improvement initiatives.
- Support internal stakeholders by providing timely regulatory input within the RA scope and coordinating assigned follow-up actions.
Additional activities
- Support the implementation and maintenance of Quality Management System activities related to Regulatory Affairs, including CAPA, audit readiness, and controlled documentation.
- Provide regulatory support to cross-functional teams within the RA scope.
- Execute other regulatory tasks and projects as assigned.
Qualifications
Required Knowledge, Skills, and Experience:
- 3–5 years' regulatory affairs experience in the medical device sector, focusing on EU regulations.
- Bachelor’s degree in Engineering, Medical Technology, or related field preferred; relevant experience accepted.
- Solid knowledge of global medical device regulations (ISO 13485, Directive 93/42/EEC, Regulation 2017/745/EU).
- Experience with sustaining, remediation, registration, labeling, CAPA, audit readiness, and other regulatory activities.
- Familiarity with EU compliance directives (RED, ROHS, Waste Framework Directive).
- Strong organizational and planning abilities, proactive and results-driven.
- Excellent interpersonal skills for international and cross-department collaboration.
- High attention to detail for accuracy and completeness.
- Proficient in English (minimum C1 level).
- Skilled with Microsoft Office and Outlook.
- Able to work on-site in Aubonne, Switzerland.
Preferred Knowledge, Skills, and Experience:
- Familiarity with EUDAMED, Swissdamed, or similar structured regulatory systems, databases, or readiness activities.
- Experience with labeling or IFU remediation, language requirement assessments, or electronic IFU implementation support.
- Experience supporting registration lifecycle maintenance, distributor-facing documentation packages, or market-specific documentation readiness.
- Experience with Smartsheet, Power BI, Jira, or similar tools used for tracking, dashboards, reporting, or workload visibility.
- Exposure to clinical trial support activities in a medical device environment.
Additional Information
Intuitive 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.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
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