Regulatory Affairs Team Lead

Principal Responsibilities

1. Support generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada. Responsible for ensuring the files are in compliance with relevant regulations and standards.
2. Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met. 
3. Support the organization in change control activities for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
4. Support regulatory agency and/or notified body audits by as needed.
5. Participate in development and approval of risk activities as well as other deliverables as related to projects. 
6. Review and approve Clinical Evaluation, PMCF, SSCP development and updates to achieve regulatory compliance.
7. Provide regulator...