Regulatory Affairs Lead

Role Summary
The Regulatory Affairs Lead is responsible for defining and executing global regulatory strategies for medical devices and combination products. This role provides strategic regulatory leadership, drives regulatory submissions and approvals, ensures compliance with global regulations, and partners with cross-functional teams to support product development, commercialization, and lifecycle management.

Key Responsibilities
Define and execute global regulatory strategies for medical devices and combination products across US, EU, and international markets.
Evaluate regulatory pathways and submission requirements for current products, design changes, manufacturing changes, and market expansions.
Provide strategic regulatory recommendations to support business and product objectives.
Lead preparation, review, approval, and submission of regulatory dossiers including FDA 510(k), PMA, De Novo, EU MDR Technical Documentation, and global registration submissions.
Manage regulatory approvals, product registrations, renewals, notified body interactions,



and authorized representative activities.
Review and approve regulatory impact assessments for product, process, manufacturing, software, supplier, and labeling changes.
Provide regulatory leadership for product lifecycle management and maintenance of global market access.
Review and approve Technical Documentation, Design Dossiers, GSPR compliance documentation, and regulatory evidence packages.
Ensure compliance with global regulations, standards, and guidance documents including EU MDR, FDA regulations, ISO 13485, ISO 14971, IEC 60601-1, ISO 20417, and ISO 15223-1.
Review and approve product labeling, IFUs, packaging artwork, UDI requirements, and promotional materials.
Provide regulatory guidance and leadership to cross-functional teams including R&D;, Quality, Clinical, Manufacturing, and Marketing.
Develop regulatory strategies for combination products and determine appropriate submission

📌 Regulatory Affairs Lead (Bengaluru)
🏢 HealthMinds Consulting
📍 Bengaluru