Regulatory Affairs Team Leader

Role Overview

• Developing global regulatory approval strategies for medical devices
• Technical and disciplinary leadership of a 13-member Regulatory Affairs team
• Development and responsibility for components of global registration and re-registration strategies
• Managing implementation through to final documentation
• Proactive regulatory advice
• Actively supporting exchanges with regulatory authorities
• Continuously expanding knowledge of regulatory requirements and modern methodologies
• Approximately 50% hands-on/operational contribution

Requirements

• Degree in a technical or natural science discipline or equivalent
• Several years of professional experience and preferably initial leadership experience in an internationally oriented Regulatory Affairs function
• Solid, up-to-date knowledge of international regulatory requirements, product liability, and relevant medical device standards/regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDR)
• Strong knowledge of regulatory software and databases and business-fluent (negotiation-level) English
• Confident communicator, strong stakeholder management skills, and clear goal/result orientation

Benefits

• High quality of living
• Cultural and recreational amenities
• Excellent transport links to Hamburg and the Baltic Sea