What are the responsibilities and job description for the Head of Regulatory Affairs US & Canada position at Greiner?
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
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