EU Regulatory Compliance Strategist – Medical Devices

Intuitive; Schweiz; On-site; CHF 120,000 - 160,000; Full time

Job summary

Intuitive is seeking a Regulatory Compliance Center (RCC) Specialist to coordinate and ensure timely execution of routine regulatory compliance activities for the European scope. Working under the Director RCC, you will advise commercial teams and support EU MDR, Swiss MedDO, and related regulatory frameworks by following established processes.

You will own local compliance processes, manage Economic Operator records, support QMS activities, and act as RAQA partner for assigned functions while

Qualifications

• 4+ years in medical device industry under US or EU regulations
• Bachelor or Master in engineering, life sciences, or equivalent
• Strong knowledge of EU MDR 2017/745 and ISO 13485:2016
• Ability to work autonomously and make informed regulatory decisions
• Excellent written and verbal communication in English and French
• Attention to detail and strong planning skills

Responsibilities

• Independently manage regulatory inquiries and tender support within defined scope
• Perform product compliance verification and regulatory assessments
• Review commercial customer communications for regulatory alignment
• Manage Economic Operator registrations and escalations to manufacturers
• Conduct regulatory surveillance and communicate findings to stakeholders
• Support audits and inspections and assist in field activities
• Act as Technical Manager when applicable and lead lifecycle regulatory activities

Skills

Regulatory affairs

Quality systems

Cross-functional collaboration

Technical communication

Education

Bachelor/Master in engineering or life sciences

Tools

MS Office

Job description

Intuitive is seeking a Regulatory Compliance Center (RCC) Specialist to coordinate and ensure timely execution of routine regulatory compliance activities for the European scope. Working under the Director RCC, you will advise commercial teams and support EU MDR, Swiss MedDO, and related regulatory frameworks by following established processes.

You will own local compliance processes, manage Economic Operator records, support QMS activities, and act as RAQA partner for assigned functions while