Complaint Management and MDR Specialist

Ready to shape the future of work? At Genpact, we don’t just adapt to change—we drive it. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges.If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that’s shaping the future, this is your moment.Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us and on LinkedIn, X, YouTube, and Facebook. Inviting applications for the role of Complaint Management and MDR Specialist We are looking for an experienced Complaint Management and MDR Specialist to support medical device complaint handling for LATAM markets. This person should have hands-on experience reviewing complaint cases, completing reportability decision trees, determining when an event is reportable, and preparing/submitting MDRs or other required vigilance reports. The role requires strong documentation skills, practical knowledge of medical device complaint requirements, and the ability to follow LATAM country guidance and reporting timelines. ResponsibilitiesReview complaint recordsAssess complaint files for missing documentation, approvals, or required actions.Complete and document activities in ETQ.Support the completion of missed investigations and follow-up activities.Complete decision trees for MDR reporting to determine reportability for US and EMEA and APACComplete Medwatch forms and submit to aligned Health AuthoritisGather and attach supporting documentation to complaint files.Ensure complaint records comply with SOPs and regulatory requirements.Coordinate with Quality, Regulatory Affairs, and product SMEs to resolve questions.Document findings and actions in project tracking tools.Escalate potential patient safety or regulatory concerns to management.Participate in team calibration sessions to ensure consistency across reviewers.Meet daily and weekly to review productivity and quality targets.Maintain complete and audit-ready documentation for all activities.Provide status updates and support the preparation of project metrics and reports. QualificationsMinimum Qualifications Experience in medical device complaint management, post-market surveillance, vigilance, regulatory affairs, or quality operations.Hands-on experience completing reportability decision trees for medical device complaints.Experience preparing and submitting MDRs and/or other adverse event reports for medical device complaints.Strong understanding of complaint intake, complaint review, reportability assessment, investigation support, and complaint closure activities.Ability to assess complaints for seriousness, malfunction, injury, death, recurrence risk, and regulatory reporting impact.Knowledge of LATAM complaint handling and vigilance guidance, including country-specific requirements and reporting expectations.Familiarity with LATAM regulatory authorities and requirements, such as ANVISA in Brazil, COFEPRIS in Mexico, ANMAT in Argentina, and other applicable local health authorities.Ability to track and meet required reporting timelines for LATAM markets and escalate potential delays or compliance risks.Experience documenting clear rationale for reportable and non-reportable decisions.Experience working in eQMS or complaint systems such as ETQ, TrackWise, Veeva Vault, Salesforce, or similar platforms.Strong attention to detail and ability to work with high-volume complaint cases accurately.Ability to partner with Regulatory Affairs, Quality, Medical Safety, Complaint Handling, and regional LATAM teams.Strong written and verbal communication skills in English; Spanish and/or Portuguese preferred.Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Pharmacy, Nursing, or a related field preferred. Preferred QualificationsPrior experience supporting complaint handling, complaint remediation or backlog reduction projects.Experience supporting audits, inspections, or regulatory responses related to complaint handling or vigilance reporting.Knowledge of ISO 13485, ISO 14971, FDA MDR, and global medical device vigilance expectations.Experience working with LATAM regional teams or local country affiliates. Why join Genpact?Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovationMake an impact – Drive change for global enterprises and solve business challenges that matterAccelerate your career – Get hands-on experience, mentorship, and continuous learning opportunitiesWork with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every dayThrive 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 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. Postúlate directamente en CazVid.