About this role
Primary Function of Position:
Role with European scope. Under the supervision of Director RCC, the RCC Specialist will coordinate and ensure timely execution and consistency of routine and cross-functional compliance activities. She/He will act as a subject-matter contributor, ensuring regulatory compliance and advising commercial teams. She/he will play a key role in ensuring compliance with the EU Medical Device Regulation (EU MDR), Swiss Medical Devices Ordinance (Swiss MedDO) and pertinent regulatory frameworks by following established processes.
Roles and Responsibilities:
Routine / Operations:
Independently manage customer regulatory inquiries and tender support within defined scopePerform product compliance verification and document regulatory assessmentsSupport review of commercial customer communicationsManage Economic Operator notifications and escalation to manufacturerPerform regulatory surveillance activities, including impact assessments and communication to stakeholders (Corporate and SMEs)Support site KPIs and management review inputsActively support audits and inspectionsAct as technical Manager (when applicable)Compliance & QMS:
Own local compliance processes within assigned scopeMaintain Economic Operator records and registrationsSupport Quality Agreement execution, implementation and tracking for EU service providersExecute EU commercial QMS activities (procedures, support, internal audits)Ensure timely closure and documentation of assigned compliance activitiesBusiness Support:
Lead regulatory activities for product lifecycle processesAct as RAQA binôme for assigned commercial functionsSupport training center managementParticipate in field activities to identify compliance gapsSupport customer relationship management and issue resolution Required Knowledge, Skills, and Experience:
At least 4+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairsA Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)Strong knowledge of EU MDR 2017/745/EUand ISO 13485:2016Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for resultsExcellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable directionOrientation for work result details, with emphasis on accuracy and completenessComputer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)Language: Fluent English and French Preferred Knowledge, Skills, and Experience:
Lead auditor certification for ISO 13485 and knowledge of WW regulations#LI-hybrid
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.