Service Delivery Leader - Regulatory Affairs - Operations 3

Service Delivery Leader - Regulatory Affairs - Operations Ready to turn bold ideas into real-world impact?  At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory , our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI , our breakthrough solutions tackle companies’ most complex challenges.   If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.    Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.  Get to know us at genpact.com and on LinkedIn , YouTube , X , and Facebook .

Provide regulatory leadership to meet industry standards, applying in-depth knowledge of client-specific and regulatory requirements, guidelines, and best practices.

Prepare regulatory submissions for class I, IIa, IIb, and III medical devices for global markets.

Develop preliminary regulatory strategies for key markets to support new product development activities.

Monitor regulatory agencies and industry organizations for changes in regulations, communicating updates to the company.

Provide a regulatory perspective on validation and stability reports, and post-marketing surveillance.

Maintain registration documentation necessary for international market registration, including technical files, Design Dossiers, IFUs, product labeling, Declarations of Conformity, and Clinical Evaluations.

Act as an accountable agent on behalf of the client to global regulatory bodies, leading and supporting the regulatory team in related activities.

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs Certifications PMP - UdemyUdemy, Set of certifications from IT Infrastructure Library (ITIL) - EXINEXIN, Six Sigma Black Belt Certification - BeingcertBeingcert Required Skills Regulatory Affair Management Language English (Required) Language Proficiency - Proficient - C2 Additional Job Location - Job Type Regular Master Skill List - Regulatory Affairs - Operations Remote Type - Hybrid Work Shift - Flex Time (India) Why join Genpact? •     Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter •     Make an impact – Help global enterprises solve business challenges that matter  •     Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead •     Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day  •     Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress    Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.   Let’s build tomorrow together.    Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation,