Regulatory Compliance Commercial Specialist (Temporary until Oct 2027)

About the role

Intuitive, a leader in robotic-assisted surgery, is looking for a Regulatory Compliance Commercial Specialist for a temporary role until October 2027, based in Aubonne. The position has a European scope and reports to the Director RCC. It coordinates routine and cross-functional compliance activities, ensures regulatory compliance and advises commercial teams, with a focus on the EU Medical Device Regulation (EU MDR) and the Swiss Medical Devices Ordinance.

Key responsibilities

• Independently manage customer regulatory inquiries and tender support within the defined scope
• Verify product compliance and document regulatory assessments
• Review commercial customer communications and manage Economic Operator notifications and escalations to the manufacturer
• Carry out regulatory surveillance, including impact assessments and communication to stakeholders (corporate and SMEs)
• Support site KPIs, management reviews, audits and inspections, and act as technical manager when applicable
• Own local compliance processes, maintain Economic Operator records and registrations, and close compliance activities with proper documentation
• Support Quality Agreement execution and EU commercial QMS activities (procedures, internal audits)
• Lead regulatory activities for product lifecycle, act as RAQA binôme, support training centre management and field activities, and support customer relationship management

Required profile

• At least 4 years' experience in the medical device industry under US or EU regulation, including at least 3 years in quality system management, quality manufacturing or regulatory affairs
• Bachelor's degree, engineering or master's degree in medical technology, life sciences or similar (or equivalent experience)
• Fluent English and French
• Preferred: lead auditor certification for ISO 13485 and knowledge of WW regulations

Required skills

• Strong knowledge of EU MDR 2017/745/EU and ISO 13485:2016
• Autonomous work and sound daily judgment
• Organizational and planning skills, computer literacy (Microsoft Word, Excel, PowerPoint, Outlook)