Primary Location: France-France-Bordeaux
Requisition ID: 200408
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
Acting European Authorized Representative under EU MDR and EU MDD. Management of regulatory operations, regulatory registrations/filings, post-market surveillance, QMS, liaison with Corporate & global RAQA teams, advocacy with government bodies and manufacturer associations across Western Europe (France, Benelux, Nordic countries). Ensure proper liaison with sales, marketing and service teams as well as all other enabling functions.
Roles and Responsibilities:
Acting European Authorized Representative under EU MDR and EU MDD regulatory frameworks
As part of the WE commercial leadership team ensure compliance of all Intuitive Surgical SAS activities with applicable regulation; guide and influence operational decisions accordingly and develop RAQA strategy aligned with WE business objectives
Identify, develop and implement processes to support compliance activities related to post market surveillance, including complaint management, vigilance reporting and field actions
Develop and implement a QMS for WE region, aligned with Corporate QMS and tailored for the scope of WE activities
Represent Intuitive Surgical with competent authorities (eg ANSM) and manufacturer associations (eg Snitem) to
ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures.
carry out Intuitive Surgical advocacy activities (in Intuitive Surgical’s name or through trade associations) to defend and promote company policy objectives to regulatory and policy making bodies
maintain a constructive relationship with health authorities through frequent and transparent dialogue
develop and strengthen partnership with ANSM, as the leading Competent Authority for the European Authorized Representative
Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
Develop & implement regulatory strategy to obtain regulatory clearance and enable commercial market opportunities of new products or existing portfolio
Act as WE Subject Matter Expert with regards to local regulation; support RA intelligence and regulatory surveillance process
Act as a liaison between Intuitive Surgical SAS to Regulatory affairs and quality compliance global and corporate headquarters in support of regulatory and quality system activities
Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, audit
Provide support to clinical activities
Other projects may be assigned as necessary
Travel: up to 20%
Required Knowledge, Skills, and Experience:
- At least 10+ 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)
- Deep knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, 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 9001, 13485 and knowledge of WW regulations
- Good knowledge of medical device reprocessing/sterilization or refurbishment requirements
- Team management experience of small team size associated with goals objectives definition / people development.