Regulatory Compliance Commercial Specialist - temporary role until October 2027

Job description

Primary Function of Position

Role with European scope. Under the supervision of Director RCC, the RCC Specialist will coordinate and ensure timely execution and consistency of routine and cross-functional compliance activities. She/He will act as a subject-matter contributor, ensuring regulatory compliance and advising commercial teams. She/he will play a key role in ensuring compliance with the EU Medical Device Regulation (EU MDR), Swiss Medical Devices Ordinance (Swiss MedDO) and pertinent regulatory frameworks by following established processes.

Roles and Responsibilities

Routine / Operations: Independently manage customer regulatory inquiries and tender support within defined scope

• Perform product compliance verification and document regulatory assessments
• Support review of commercial customer communications Manage Economic Operator notifications and escalation to manufacturer
• Perform regulatory surveillance activities, including impact assessments and communication to stakeholders (Corporate and SMEs)
• Support site KPIs and management review inputs Actively support audits and inspections
• Act as technical Manager (when applicable)

Compliance & QMS

• Own local compliance processes within assigned scope Maintain Economic Operator records and registrations Support Quality Agreement execution, implementation and tracking for EU service providers Execute EU commercial QMS activities (procedures, support, internal audits)
• Ensure timely closure and documentation of assigned compliance activities Business Support: Lead regulatory activities for product lifecycle processes
• Act as RAQA binôme for assigned commercial functions
• Support training center management
• Participate in field activities to identify compliance gaps
• Support customer relationship management and issue resolution

Qualifications

Required Knowledge, Skills, and Experience

At least 4+ 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)
• Strong knowledge of EU MDR 2017/745/EUand 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 13485 and knowledge of WW regulations #LI-hybrid