Lead Specialist Regulatory Affairs

Overview

Supports regulatory activities for assigned Maternal Infant Care products and markets across the product lifecycle, learning and applying country- and region-specific regulations to prepare documentation and support submissions and compliance.

What you'll do

• 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/registrations and post-market activities while working with healthcare regulatory bodies globally.
• 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, and applicable operating environments; build awareness of adjacent product lines.
• Research relevant regulatory and technical information, help evaluate options, and contribute to practical solutions for low- to moderate-complexity matters.
• Follow established procedures and exercise sound judgment; identify questions, risks, or trade-offs and seek management or subject-matter-expert input when appropriate.
• Organize individual work, manage multiple priorities, and deliver assigned work on agreed timelines with limited direct oversight as experience develops.
• Communicate regulatory information clearly and concisely through written, verbal, virtual, and in-person channels, adapting the approach to the audience and situation.
• Collaborate respectfully with Regulatory Affairs colleagues and cross-functional partners, including Quality Assurance, Engineering/Design, Manufacturing, Clinical, Marketing, and business stakeholders.
• Maintain integrity, confidentiality, data accuracy, and high quality standards in all interactions, records, and deliverables.

What you'll need

• Bachelor's degree from an accredited university.
• 6-8 years of relevant professional experience (Regulatory Affairs, Quality Assurance, product design or engineering, manufacturing, clinical, laboratory, compliance, or another role within a regulated industry).
• Minimum of 3+ years of experience working in a regulated field.
• Strong written and oral communication skills in English.
• Ability to understand technical documentation and execute associated procedures.
• Strong communication, project-management, and organizational skills.
• Ability to research relevant information, analyze issues, explain findings clearly, and recognize when additional guidance is needed.
• Clear and timely communication, active listening, and concise professional writing.
• Collaborative approach and ability to work effectively across functions in a matrix organization.
• Team-oriented and responsive to customer needs.
• Integrity, transparency, respect, adaptability, self-motivation, sound judgment, and calmness under pressure.
• Ability to work independently in a fast-paced environment and adapt to change; attention to detail and results orientation.
• Empathy, humility, kindness, and professionalism in working relationships.

Nice to have

• Degree in science, engineering, health sciences, legal studies, regulatory affairs, quality, or a related discipline.
• Regulatory Affairs experience.

Details

• Location: Bengaluru, India (Kalyani Platina, Magnolia).
• Relocation assistance provided: Yes.