Assistant Manager - Regulatory Affairs

Job Description:

Responsibilities

1. Regulatory Compliance

• Review and ensure compliance with regulatory requirements for medical devices.
• Prepare and submit regulatory filings, including 510(k) submissions, CE marking, CDSCO, MDSAP, ANVISA, TFDA, and other international registrations.
• Monitor regulatory changes and update internal stakeholders on implications for products and processes.
• Compliance with local pollution control act, legal meteorology act, Medical Devices Rules 2017.
• Conduct Post Market Surveillance, Post Market Clinical Follow up, Risk Management, Periodic Safety Update Report, Manage Product Safety, General Safety and Performance Requirements (GSPR), Essential Safety Requirements, Eudamed Registration.
• Obtain Free sales certificate, Non-Conviction certificate, Market Standing Certificate from Local and Foreign bodies.
• Obtain test and manufacturing license from CDSCO.
• Obtain GMP, GLP, ISO 13485, ISO 9001 certificates from the authorities.

2. Quality Assurance Support

• Collaborate with Quality Assurance to ensure regulatory requirements are integrated into quality systems.
• Assist in audits and inspections related to regulatory compliance.

3. Documentation Management

• Maintain and manage regulatory documentation, including regulatory submissions, approvals, and correspondence with regulatory agencies.
• Ensure accuracy, completeness, and timeliness of regulatory submissions and responses.

4. Strategic Regulatory Planning

• Develop and implement regulatory strategies for new product development and product lifecycle management.
• Provide regulatory guidance to cross-functional teams on regulatory requirements and timelines.

5. Training and Development

• Conduct training sessions for internal stakeholders on regulatory compliance and updates.
• Stay updated on industry trends, regulatory changes, and best practices through continuous learning.

6. Cross-Functional Collaboration

• Work closely with R&D, Clinical Affairs, Quality Assurance, and Production to ensure regulatory compliance throughout the product lifecycle.
• Facilitate communication between regulatory agencies and internal teams.