Specialist - 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.
Job Description
Responsibilities: Research and stay updated on regulations relevant to the industry. Provide guidance and training to staff on compliance matters. Monitor and report on compliance issues to management.
Hands on experience with Medical device UDI data aggregation, country specific UDI requirements guidelines/Global UDI Regulations, labels, medical device UDI attributes and terminology, Implementation Global UDI data clean up strategy..
Knowledge of the European Medical Device Regulation (EU MDR), EUDAMED, FDA GUDID, Understanding of Technical file content.
Understanding on labelling artwork, labels
Prior experience in PIM system, SAP, Master control, RIM, Regulatory tool and Processes is desired.
Advance data Analysis skills, advance excel, data analysis, data science.
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)
Required Skills
Client Relations, Collaboration Tools, Data Analytics, Personal Effectiveness, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations
Language
English (Required)
Language Proficiency -
Proficient - C2
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Operations
Remote Type -
Hybrid
Work Shift -
Evening Job (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, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.
