Assistant Manager/Manager - Regulatory Affairs

OVERVIEW

To assist the Manager in managing and overseeing the HNGC RA team and ensuring that products manufactured and the company comply with regulatory and statutory requirements.

DUTIES AND RESPONSIBILITIES

1. Ensure products manufactured or distributed comply with the required regulations.
2. Manage and facilitate all regulatory submissions related to establishment and product.
3. Liaise with regulatory authorities and designated agents.
4. Provide regulatory support to product development and current marketed products.
5. Keep up to date with changes in regulations.
6. Ensure company compliance with required regulations.
7. Update regulatory documentation.
8. Review labeling, storage, and packaging requirements in accordance with regulatory requirements.
9. Responsible for reviewing, documenting, logging, maintaining, and/or initiating the investigation of potentially serious complaints.
10. Address CAPA deficiencies arising from scheduled and/or unscheduled audits and customer complaints, focusing on effective corrective action and sustainable preventive action.
11. Conduct Quality Audits.
12. Provide training, guidance, and coaching to subordinates (if any).
13. Any other tasks assigned by the superior.

REQUIREMENTS

1. Bachelor's Degree in Science, Engineering, or any equivalent.
2. Minimum 6 years of experience in a Medical Device Regulatory position or similar roles and responsibilities preferred.
3. Knowledge of manufacturing processes and operations.
4. Experience with product testing, licensing, registration, and certification.
5. Familiarity with ISO 14971: Risk Management Assessment.
6. Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
7. Strong compliance with organizational processes and systems and regulatory requirements.
8. Experience assisting managers in preparing documentation and drafting product information for product registration or licensing.
9. Sound knowledge of medical device regulations.
10. Experience addressing CAPA deficiencies with a focus on effective corrective action and sustainable preventive action.
11. Ability to handle customer inquiries and resolve regulatory compliance issues.
12. Skills in scheduling and coordinating the work and activities of others to accomplish assigned tasks.
13. Able to establish strong relationships with other units or divisions and maintain them over time.
14. Experience leading cross-functional task forces consisting of team members from other units or divisions.
15. Ability to coach junior team members in delivering results.