Specialized Regulatory Manager

Primary Responsibilities:

1. Regulatory Compliance: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 and other global standards.
2. Submission Preparation: Prepare and submit regulatory submissions, including 510(k) notifications, PMA applications, IDEs, and post-market surveillance reports.
3. Analyze the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.
4. Responsible for owning & leading entire Medical Device for remediation according to customer requirement.
5. Execute the remediation project by guiding the remediation engineers.
6. Review of the artifacts modified or prepared for remediation projects.
7. Labeling and Packaging: Ensure compliance with labeling and packaging regulations, including content, design, and format requirements.
8. Prepare technical documentation dossiers for regulatory submissions, including design controls, risk management plans, and performance testing data.
9. Product Development: Collaborate with cross-functional teams to develop new products, ensuring regulatory compliance throughout the product lifecycle.
10. Audits and Inspections: Coordinate internal audits and prepare for FDA inspections by ensuring compliance with regulations and maintaining accurate records.
11. Compliance Monitoring: Monitor compliance with company policies, procedures, and regulatory requirements, identifying areas for improvement and implementing corrective actions as needed.
12. Manage the regulatory submission process for new and existing medical devices, working closely with notified bodies and regulatory agencies.
13. Track regulatory timelines and milestones, ensuring timely submissions and approvals.

Desired Skills and Qualifications:

1. Bachelor / Diploma / master degree in a related field, such as biomedical engineering, Mechanical Engineering, Electrical and Electronics Engineering or related life science.
2. 15-20 years of experience in medical device industry
3. Minimum 8 years of experience in medical device regulatory affairs, preferably with experience in the active medical device (Entire life cycle).
4. Hands on experience in DHF Gap Assessment and Remediation for FDA 21 CFR Part 820, EU MDR.
5. Experience working in Class II or Class III products preferred.