Lead Specialist Regulatory Affairs

About the role

The Regulatory Affairs supports regulatory activities for assigned products and markets throughout the product lifecycle.

What you'll do

• Provide global RA support for registration planning, submissions, notified body and quality system audits, and program implementation
• Contribute to writing and editing technical documents and research, analyze, integrate, and organize information from diverse sources for regulatory submissions
• Support development of practical go-to-market strategies by identifying regulatory requirements, constraints, dependencies, and timelines, and escalating concerns early
• Monitor changes to applicable regulations and standards and assist in assessing potential impact on assigned products, markets, documentation, and regulatory commitments
• Develop and maintain working technical knowledge of assigned products, including intended use, design and performance characteristics, manufacturing context

What you need

• 6–8 yrs of experience
• Regulatory affairs
• Documentation
• Communication
• Go-to-market
• Product knowledge
• B.Tech or B.E.