Management Trainee-Medical Device Reporting

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Job Description: 

Inviting applications for the role of Management Trainee – Medical Device Reporting (MDR)  

The Medical Device Reporting Analyst will be responsible for managing and coordinating all aspects of medical device reporting within the organization or medical device manufacturing company. This position will play a crucial role in ensuring compliance with regulatory requirements and facilitating the timely and accurate reporting of adverse events and product malfunctions associated with medical devices. 

Responsibilities 

• Stay up to date with the latest regulations and guidelines related to medical device reporting, including those issued by regulatory bodies such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA). 

• Representatives within the countries that perform the assessment, creation, and submission of Medical Device Reporting. Coordination and execution of the Medical Device Incident reporting handling process.  

• Timely adverse event reporting. Overall responsibility for making Medical Device Reporting decisions. Managing Health Authority Requests. Responsible for vigilance and adverse event reporting to local Health Authority ensuring compliance with the standards. 

• Responsible for worldwide and importer MDR reporting. Adverse Event Reporting\: Responsible for assessing complaints to determine reportability in various regions, drafting and submitting Adverse Event (AE), death and malfunction report in a timely manner as per regulations. 

• Receive, review, and evaluate reports of adverse events or incidents associated with medical devices. Conduct thorough investigations and gather relevant information to determine reportability. 

• Assess the severity and impact of adverse events on patients or users. Determine if events meet the criteria for medical device reporting and escalate as necessary. 

• Documentation and Record Keeping\: Maintain accurate and complete documentation related to adverse event reports. 

• Ensure timely and appropriate entry of data into the designated reporting system or database. Monitor and track the progress of investigations, follow-up actions, and report submissions. 

• Prepare and maintain necessary records, files, and documentation in accordance with regulatory requirements. 

• Reporting and Communication\: Prepare and submit medical device reports (MDRs) or vigilance reports to regulatory authorities within the prescribed timelines. Collaborate with cross-functional teams, including quality assurance, regulatory affairs, and medical affairs, to gather relevant information for reporting purposes. 

• Communicate with regulatory authorities, customers, and internal stakeholders regarding medical device reporting matters. 

• Provide guidance and support to internal teams on medical device reporting requirements. 

• Process Improvement and Training\: Identify areas for process improvement and implement corrective actions to enhance the medical device reporting process. 

• Develop and deliver training programs on medical device reporting regulations, procedures, and best practices to internal staff as needed. 

• Participate in internal and external audits to ensure compliance and address any findings or observations related to medical device reporting. 

Qualifications we seek in you! 

Preferred Qualifications 

•  Bachelor's degree in a relevant scientific or healthcare discipline (e.g., biomedical engineering, nursing, pharmacology) or equivalent experience. 

• Advanced English level, C1 is preferred. In-depth knowledge of medical device regulations and guidelines (e.g., FDA, EMA, ISO 13485) 

• Medical devices complaint handling experience. 

• Experience working with complaint management systems as EtQ and/or Sales Force based software. 

• Familiarity with adverse event reporting requirements and processes. 

Why join Genpact?  

• Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovation  

• Make an impact – Drive change for global enterprises and solve business challenges that matter  

• Accelerate your career – Get hands-on experience, mentorship, and continuous learning opportunities  

• 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 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.