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 Senior Associate - Regulatory Affairs (RA) Your job will involve to setup and ensure process develops preemptive solutions for potential regulatory hurdles and ensures the quality of submissions to worldwide agencies to maximize the likelihood of successful review. What will your day-to-day role involve Responsibilities Interaction: . Provide advice for the establishment and maintenance of management policies, such as quality, environment, and human rights. . Works with Ops leads and customers to design, implement and drive Value Generating [VG] roadmaps. Activity: . Monitor and interpret product regulations: responsible for continuously monitoring and interpreting product-related laws and regulations to ensure that the company%27s products comply with relevant requirements. . Update Risk Management Files (RMF): responsible for updating risk management files to ensure timely recording and management of product risks. . Issue compliance statements: responsible for issuing compliance statements to indicate that the products comply with relevant regulations and standards. . Product and facility registration: responsible for product and facility registration to ensure compliance with the relevant registration requirements. Qualifications we seek in you! Minimum qualifications . Knowledge of overall quality management systems based on ISO, FDA-QSR, QMS, and other standards. . In-depth knowledge and practical experience in regulatory management related to company%27s business and products. . Thorough understanding of market, business, products, and stakeholders%27 knowledge and practical experience. . High motivation and flexibility to learn new things. . Ability to work under time pressure. Preferred Qualifications . High motivation and agility to learn new things . Ability to work under time pressure . Good professional interpersonal and communication skills . Regulatory affairs background/medical device background advantageous 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 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 %27starter kit,%27 paying to apply, or purchasing equipment or training.
