EU Regulatory Compliance Specialist – Commercial (MDR)

Intuitive; Aubonne; On-site; CHF 120,000 - 170,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, is seeking a Regulatory Compliance Commercial Specialist for a European scope role based onsite in Switzerland. The temporary position supports EU MDR, Swiss MedDO, and related regulatory activities, coordinating with commercial teams to ensure compliant, timely execution.

You will manage regulatory inquiries, perform product compliance assessments, handle Economic Operator registrations, and assist audits.

Qualifications

• At least 4+ years in medical device industry under US/EU regulation, with 3+ years in quality system management, quality manufacturing or regulatory affairs.
• Bachelor or higher in engineering, life sciences or related field.
• Strong knowledge of EU MDR 2017/745/EU and ISO 13485:2016.
• Ability to work autonomously and apply regulatory knowledge.
• Excellent verbal and written communication and presentation skills.
• Fluent English and French.

Responsibilities

• Independently manage regulatory inquiries and tender support.
• Perform product compliance verification and regulatory assessments.
• Support review of commercial customer communications.
• Manage Economic Operator notifications and escalation to manufacturer.
• Perform regulatory surveillance activities and stakeholder communications.
• Act as technical Manager when applicable.
• Support audits and inspections.

Skills

EU MDR knowledge

ISO 13485 knowledge

Regulatory affairs

Medical devices QMS

English & French

Education

Bachelor/Master in medical technology or life sciences

Job description

Intuitive, a global leader in robotic-assisted surgery, is seeking a Regulatory Compliance Commercial Specialist for a European scope role based onsite in Switzerland. The temporary position supports EU MDR, Swiss MedDO, and related regulatory activities, coordinating with commercial teams to ensure compliant, timely execution.

You will manage regulatory inquiries, perform product compliance assessments, handle Economic Operator registrations, and assist audits.