About the Job
Key responsibilities:1. Train NPD teams on applicable regulatory requirements.
2. Review and ensure compliance with regulatory standards and processes.
3. Assist in preparing and maintaining technical files/dossiers for submissions.
4. Interface with and lead communications with Notified Bodies.
5. Review adverse event data from customer complaints and ensure PMS reporting.
6. Track and implement updates to standards and regulatory requirements across the organization.
7. Prepare regulatory submissions for product registration, licensing, and renewals.
8. Support implementation of new standards into regulatory procedures.
9. Plan and manage budgets for regulatory approvals, testing, and training.
10. Maintain trackers for regulatory licenses, clearances, and applicable standards.
Number of Openings
1 openingsSkills
Team Management, English Proficiency (Spoken), English Proficiency (Written), Quality Assurance/Quality Control (QA/QC)
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