Medical Device Reporting Specialist
hace 3 días
About Us
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.
Our Purpose
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.
Job Overview
We invite applications for the role of Medical Device Reporting Specialist – Medical Device Reporting Analyst. 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.
Key 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.
- Coordinate and execute 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.
- Aess 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.
Required Skills and Qualifications
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.
Estimated Salary Range
$60,000 - $100,000 per year.
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