14 Oct
|
GE Healthcare
|
Bengaluru
14 Oct
GE Healthcare
Bengaluru
Job Description Summary
The Regulatory Affairs supports regulatory activities for assigned products and markets throughout the product lifecycle. This level role is designed for an early regulatory career professional who will learn and apply country- and region-specific regulations, standards, internal procedures, and product knowledge to prepare high-quality regulatory documentation, support submissions and compliance deliverables, and contribute to timely market access and continued product compliance. Provides regulatory support for Maternal Infant Care regulatory programs across the product lifecycle, including global registration planning, submissions, notified body and quality system audits, program implementation, and pre- and post-market compliance.
The role works collaboratively across a matrixed organization and provides an prospect to build practical regulatory expertise while contributing to go-to-market strategies and solutions for low- to moderate-complexity regulatory matters under appropriate guidance and supervision.
Works across a cross-functional matrix and communicates regulatory strategy, risks, decisions, and program status to leadership and other stakeholders.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Key Responsibilities
• Learn and apply applicable country- and region-specific regulations, standards, guidance, and internal regulatory procedures. Understand and apply regulatory requirements and their impact on submissions and pre- and post-market compliance.
• Provide global RA support for registration planning, submissions, notified body and quality system audits, and program implementation; support compliance of premarket submissions/registratio
📌 Lead Specialist Regulatory Affairs (Bengaluru)
🏢 GE Healthcare
📍 Bengaluru