Regulatory Manager

Position Summary

The Regulatory Affairs Manager is responsible for leading regulatory strategy, planning, documentation, and submissions for medical device products across global markets, including the EU (EU MDR), United States (FDA), India (CDSCO), and other applicable regions. This role ensures compliance with all regulatory requirements throughout the product lifecycle and partners closely with cross-functional teams to support product development, registration, and market expansion.

Key Responsibilities

• Regulatory Strategy & Planning
• Develop and execute global regulatory strategies to support new product introductions, changes, and lifecycle management.
• Interpret and apply regulatory requirements for EU MDR, FDA (21 CFR 820, 807, 814, 820.30), CDSCO, and other regional regulations.
• Provide regulatory input in design reviews, risk assessments, clinical evaluations, and quality system a...