Role & responsibilities

Role Summary

The Director Regulatory Affairs & Compliance will lead the organization's regulatory strategy, quality compliance, and global product registrations for medical devices. The role is responsible for ensuring compliance with national and international regulatory requirements, including US FDA, CE (EU MDR), ISO 13485, CDSCO, and MDSAP, enabling timely product approvals and market access.

The ideal candidate should have proven experience in obtaining US FDA and CE approvals within a medical device manufacturing company and leading regulatory audits, inspections, and compliance initiatives.

Key Responsibilities
- Develop and execute global regulatory strategies for new products and lifecycle management.
- Lead regulatory submissions for US FDA, CE Mark (EU MDR), CDSCO, and other international markets.
- Ensure compliance with ISO 13485, FDA QMSR, EU MDR, MDSAP, and applicable regulatory standards.
- Manage technical documentation, regulatory submissions, licenses, and product registrations.
- Lead regulatory inspections, certification audits,



and ensure audit readiness.
- Provide regulatory guidance during product development, design changes, and post-market activities.
- Collaborate with R&D;, Quality, Manufacturing, Marketing, and Commercial teams to ensure regulatory compliance.
- Monitor changes in global regulations and implement necessary actions.
- Lead, mentor, and develop the Regulatory Affairs & Compliance team.
- Act as the primary liaison with regulatory authorities, notified bodies, and certification agencies.

Educational Qualification
- Master's degree in Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or a related field.

Experience
- 15+ years of experience in Regulatory Affairs within the medical device manufacturing industry.
- Proven hands-on experience in obtaining and maintaining US FDA and CE (EU MDR) approvals for medical devices.
- Solid knowledge of ISO 13485, FDA QMSR, EU MDR, CDSCO, and M

📌 Head- Regulatory Affairs (Pune)
🏢 Biorad Medisys
📍 Pune