Regulatory Compliance Commercial Specialist

📋 Description

• 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
• Support site KPIs and management review inputs

🎯 Requirements

• At least 4+ years’ experience in medical device industry operating according to US or EU regulation
• Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or
• Strong knowledge of EU MDR 2017/745/EU and ISO 13485:2016
• Ability to work autonomously and exercise daily judgment based on regulatory knowledge
• Demonstrated organizational and planning skills, action-oriented and can-do attitude, focused
• Excellent verbal and written communication and presentation skills, ability to distill complexity