Head - Regulatory Affairs - Medical Devices - EU/US Market

- Looking at professional experience of min 5 years into Global Regulatory Affairs and who has actively done submissions for global markets such USFDA, ANVISA, etc as the companies plan to expand to Europe and US markets.

- Incumbent should be carrying strong knowledge of relevant regulations and guidelines for medical devices, including FDA 21 CFR, EU Medical Device Regulation (MDR), and ISO 13485.

1. Strong knowledge of relevant regulations and guidelines for medical devices, including FDA 21 CFR, EU Medical Device Regulation (MDR), and ISO 13485.

2. Expertise in the preparation and submission of regulatory filings, such as pre-market clearance or approval applications, to regulatory bodies.

3. Experience with the design control process and ability to review and approve technical documents such as design specifications, testing plans, and protocols.

4. Understanding of the product development process, including design, development, testing, and manufacturing of medical devices.

5. Ability to perform gap analysis and risk management to ensure compliance with regulations and standards.

6. Experience with Quality Management Systems (QMS) and International Organization for Standardization (ISO) requirements.

7. Knowledge of the principles of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

8. Strong analytical and problem-solving skills, ability to evaluate and interpret data.

9. Strong verbal and written communication skills to effectively communicate with internal and external stakeholders.

10. Experience with electronic submission and management systems for regulatory documents.

11. Familiarity with industry standards and guidelines from various regulatory bodies worldwide.

- Team: 1 member (Team may expand in the future)