Job
Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI. Inviting applications for the role of Regulatory Engineer! In this role - The team developing industry leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest. Regulatory Engineer will be working on compliance activities for various medical devices global regulations. Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc ) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (Eg. REACH, ROHS, etc) in alignment with the quality management system Lead or support product regulatory documentation updates (eg NRTL reports, tech file, etc) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Required Qualifications Bachelor’s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system. Tools and Technologies Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard. Proficiency in interpreting, applying complex regulations, and preparing associated documentation. Excellent interpersonal communication and collaboration skills 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. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube. 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.
