Job Description
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 scope
- Perform product compliance verification and document regulatory assessments
- Support review of commercial customer communications
- Manage Economic Operator notifications and escalation to manufacturer
- Perform regulatory surveillance activities, including impact assessments and communication to stakeholders (Corporate and SMEs)
- Support site KPIs and management review inputs
- Actively support audits and inspections
- Act as technical Manager (when applicable)
Compliance & QMS:
- Own local compliance processes within assigned scope
- Maintain Economic Operator records and registrations
- Support Quality Agreement execution, implementation and tracking for EU service providers
- Execute EU commercial QMS activities (procedures, support, internal audits)
- Ensure timely closure and documentation of assigned compliance activities
Business Support:
- Lead regulatory activities for product lifecycle processes
- Act as RAQA binôme for assigned commercial functions
- Support training center management
- Participate in field activities to identify compliance gaps
- Support customer relationship management and issue resolution
Qualifications
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 affairs
- A 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 13485:2016
- Ability 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 results
- Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
- Orientation for work result details, with emphasis on accuracy and completeness
- Computer 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
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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.
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 leading company in the field of 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.
