Primary Location: Germany-Freiburg-Freiburg
Requisition ID: 192497
Primary Function of Position:
Management of regulatory operations, regulatory registrations/filings, post-market surveillance, QMS, liaison with Corporate & EMEIA RAQA teams, advocacy with government bodies and manufacturer associations across Germany and Austria. Ensure proper liaison with sales, marketing and service teams as well as all support functions.
Roles and Responsibilities:
Join the leadership team to ensure compliance of all Intuitive Surgical Ltd activities with applicable regulation; guide and influence operational decisions accordingly
Identify, develop and implement processes to support compliance activities related to post market surveillance, including complaint management, vigilance reporting and field actions
Represents Intuitive Surgical with competent authorities (eg BfArM) and manufacturer associations (eg bvMed) 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 before regulatory and policy making bodies
maintain a constructive relationship with health authorities through frequent and transparent dialogue
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 a liaison between Intuitive Surgical Ltd to Regulatory affairs and quality compliance EMEIA and corporate headquarters and other international sites in support of regulatory and quality system activities
Other projects may be assigned as necessary
People Management: determine goals and objectives while removing obstacles for the team
Travel: up to 20%
Required Knowledge, Skills, and Experience:
- At least 8+ 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.
- Proven project management experience
- Team management experience of small team size associated with goals objectives definition / people development
- 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 German
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.