Sr. Associate - 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.
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Job Description
Inviting applications for the role of SA Triage data surveillance specialist Your job will involve evaluating discovery report for all medical devices distributed by our client and generating FUC (Final Universal Code). Determines if investigation is required (Tier determination). Closure of the complaint by integrating the FUC into the ETQ Database. What will your day-to-day role involve? Responsibilities: - Interaction: - Works with end customer indirect customers and internal stakeholders of the customers - Works with Ops leads and customers to design implement and drive Value Generating [VG] roadmaps - Activity: - The candidate will be doing a technical analysis and evaluate the outcome of the problem. - Receiving reports from field engineers technicians - they are looking at reports and determining if the problem is an issue or a non-issue from a patient safety perspective - Determine the severity of the problem and next actions. - Entering info from the service report into the digital tool (ERP) - ETQ - Make a decision and complete evaluation by classifying the issue into a tier. - They have some evaluation options (IUC - intake universal code)- e.g. - Someone got hurt in the incident - Talking to the technicians who sent the reports for more details - Support the training of employees on the complaint process and regulatory requirements. - Explain complaint files during audit situations. - Reviews files for closure and completeness. - Determination if investigation is required (Tier determination) - Final evaluation & closure of Tier 3 complaint
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, 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, Generative AI, Lean Six Sigma (LSS), Personal Effectiveness, Storytelling
Language
English
Language Proficiency -
Proficient - C2
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Operations
Remote Type -
Office
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.
