Job
Description
With a startup spirit and 125,000+ curious and courageous minds, we have the expertise to go deep with the worlds biggest brands and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. Were harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we’re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Permanent role WFO Shift Timings 2 PM -11 PM / 6:30 PM 3:30 AM IST Location – Gurgaon __________________________________________________________________________________________________________________________________________________________________ 1. Job Tile Medical Device Reporng Analyst 2. Job Descripon The Medical Device Reporng Analyst will be responsible for managing and coordinang all aspects of medical device reporng within the organiza¢on or medical device manufacturing company. This posi¢on will play a crucial role in ensuring compliance with regulatory requirements and facilita¢ng the ¢mely and accurate repor¢ng of adverse events and product malfunc¢ons associated with medical devices. 3. Qualica¢ons and Educa¢on • Bachelor's degree in a relevant scien¢c or healthcare discipline (e.g., biomedical engineering, nursing, pharmacology) or equivalent experience. • • • • • • • In-depth knowledge of medical device regula¢ons and guidelines (e.g., FDA, EMA, ISO 13485). Familiarity with adverse event repor¢ng requirements and processes. Strong analy¢cal and problem-solving skills. Excellent a¢en¢on to detail and accuracy. Eec¢ve communica¢on and interpersonal skills. Ability to work independently and collabora¢vely in a team environment. Prociency in using so¢ware applica¢ons for data management and repor¢ng. Medical Device Reporting Analyst GDOCOP-0006-01 __________________________________________________________________________________________________________________________________________________________________ 4. Responsibili¢es and Authori¢es Regulatory Compliance: • Stay up to date with the latest regula¢ons and guidelines related to medical device repor¢ng, including those issued by regulatory bodies such as the U.S. Food and Drug Administra¢on (FDA) or European Medicines Agency (EMA). • Ensure compliance with applicable regula¢ons and standards throughout the repor¢ng process. Adverse Event Repor¢ng: • • • • Receive, review, and evaluate reports of adverse events or incidents associated with medical devices. Conduct thorough inves¢ga¢ons and gather relevant informa¢on to determine reportability. Assess the severity and impact of adverse events on pa¢ents or users. Determine if events meet the criteria for medical device repor¢ng and escalate as necessary. Documenta¢on and Record Keeping: • • • • Maintain accurate and complete documenta¢on related to adverse event reports. Ensure ¢mely and appropriate entry of data into the designated repor¢ng system or database. Monitor and track the progress of inves¢ga¢ons, follow-up ac¢ons, and report submissions. Prepare and maintain necessary records, les, and documenta¢on in accordance with regulatory requirements. Repor¢ng and Communica¢on: • • • • Prepare and submit medical device reports (MDRs) or vigilance reports to regulatory authori¢es within the prescribed ¢melines. Collaborate with cross-func¢onal teams, including quality assurance, regulatory aairs, and medical aairs, to gather relevant informa¢on for repor¢ng purposes. Communicate with regulatory authori¢es, customers, and internal stakeholders regarding medical device repor¢ng ma¢ers. Provide guidance and support to internal teams on medical device repor¢ng requirements. Medical Device Reporting Analyst GDOCOP-0006-01 __________________________________________________________________________________________________________________________________________________________________ Process Improvement and Training: • • • Iden¢fy areas for process improvement and implement correc¢ve ac¢ons to enhance the medical device repor¢ng process. Develop and deliver training programs on medical device repor¢ng regula¢ons, procedures, and best prac¢ces to internal sta as needed. Par¢cipate in internal and external audits to ensure compliance and address any ndings or observa¢ons related to medical device repor¢ng. 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 diversity and inclusion, 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.
