Regulatory Compliance Manager
Overview
Our client manufactures and distributes high quality patient monitoring and medical surgical consumables. They are aggressively growing and are looking for a regulatory compliance manager to join their team. If you would like to work in a global team who encourages creativity, open for challenges and proactive in finding solutions, this is the perfect opportunity!

Tasks

• Support in internal and external audits
• Responsible for review, development, remediation and approval of Device History Files and/or Technical Documentation of medical devices according to regulatory requirements (MDR and FDA)
• Regulatory submissions in all markets including license renewal and annual registrations
• Review design changes and support new product design control process with regulatory inputs and decisions
• Evaluate change impacts on products and processes and take regulatory action
• Maintain knowledgeable on regulatory requirements and market changes and support in regulatory strategy planning
• Communication with regulatory agencies
• Support the establishment of quality standards for products, processes, and procedures

• 3+ years professional experience in Medical Device Industry
• Completed medical-technical or scientific university/university of applied sciences studies, or a comparable education
• Thorough knowledge of regulatory requirements such as ISO 13485, CFR, MDR etc.
• Experience in submission of 510(k) premarket notifications, and identifying qualifying devices, PMAs, and CE Technical Documentation
• Good organizational skills, analytical thinking and a high level of reliability
• Fluency in English and German