Head of Regulatory Affairs US & Canada

Your challenge

• Establishing compliant and efficient group processes
• Ensuring compliant and timely product registration and re-registrations for US, and Canada
• Main contact for the authorities
• Ensuring compliant clearances and submission files
• Ensuring compliant and efficient regulatory submission strategies in close collaboration with R&D and Product Management (BU)
• Providing regulatory input and strategy to new product development and product lifecycle planning
• Developing and maintaining relationships with regulatory agencies, ensuring timely submissions and approvals for products/services.
• Monitoring and assessing internal and external quality standards, leading continuous improvement initiatives in alignment with the global QM system
• Monitoring validity of licenses, registrations and listings and renew in time
• Driving the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the global GBO organization
• Reviewing and approving marketing material (website, product catalogue, training material, social media,…)
• Reviewing and approving device labeling
• Evaluating FDA medical device reportability of complaints/events
• Coordination of Field Safety Corrective Actions and authority reporting

Your Profile

• Master’s degree in a relevant life-science or engineering field
• Proven experience in international FDA regulatory affairs (10+ years)
• Proven experience in medical device industry (10+ years)
• In-depth knowledge of international quality standards and regulatory requirements (ISO and cGMP)
• Understanding of state-of-the-art QM processes and tools
• Managerial and leadership capability
• Ability to take initiative and work without close supervision
• Experience with international companies/cultures of great advantage
• Fluent in English