Regulatory Affairs Manager at Alkem MedTech… · Mumbai(Lo…

1. JOB SUMMARY

The Regulatory Affairs (RA) Manager is responsible for overseeing regulatory strategy, submissions, and compliance activities to ensure that medical devices meet applicable regulatory requirements in domestic and international markets. This role leads regulatory activities related to product registration, lifecycle management, and regulatory intelligence. The RA Manager collaborates with cross-functional teams to ensure timely approvals and sustained regulatory compliance throughout the product lifecycle.

2. ROLE & RESPONSIBILITY

Regulatory Strategy & Submission Management:

• Develop and implement regulatory strategies for product registration in compliance with applicable regulations (e.g., MDR 2017, CDSCO, US FDA, CE Marking).
• Prepare, review, and submit regulatory dossiers including Technical File, Design Dossier, STED, 510(k), and other submissions as applicable.
• Coordinate with regulatory authorities and notified bodies for approvals, queries, and inspections.

Regulatory Compliance & Lifecycle Management:

• Ensure ongoing compliance with applicable standards and regulations such as ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, and other regional requirements.
• Maintain regulatory approvals, licenses, and product registrations.
• Manage product changes, variations, renewals, and post-approval submissions.

Documentation & Technical File Management:

• Review and approve regulatory sections of Technical Documentation including risk management, clinical evaluation, labeling, and IFU.
• Ensure alignment between regulatory documentation and QMS documentation.
• Maintain updated regulatory records and submission trackers.

Regulatory Intelligence & Updates:

• Monitor changes in global regulatory requirements and assess impact on company products.
• Provide regulatory guidance to internal teams regarding new regulations and compliance requirements.

Cross-Functional Coordination:

• Work closely with Quality, R&D, Manufacturing, Clinical, and Marketing teams to support regulatory compliance.
• Provide regulatory input during product development, design changes, and market expansion.

Audit & Inspection Support:

• Act as regulatory representative during audits and inspections by regulatory authorities and notified bodies.
• Support internal and external audits related to regulatory compliance.

Training & Team Leadership:

• Train cross-functional teams on regulatory requirements and submission processes.
• Lead and mentor the regulatory team to ensure timely and compliant submissions.

3. AUTHORITY

• Regulatory submission approval and signatory authority
• Liaison with Regulatory Authorities and Notified Bodies
• Approval of regulatory documentation (Technical File, STED, DMR regulatory sections)
• Product registration and license management
• Regulatory strategy approval for new markets
• Review and approval of labeling, IFU, and promotional materials from regulatory perspective
• Participation in Management Review Meeting (MRM)