Medical Device Reporting Analyst/Medical Device Reporting Specialist

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

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1. Job Tiê€le
Medical Device Reporêng Analyst
2. Job Descripêon
The Medical Device Reporê€ng Analyst will be responsible for managing and coordinaê€ng all aspects of medical device
reporê€ng within the organizaꢀon or medical device manufacturing company. This posiꢀon will play a crucial role in ensuring
compliance with regulatory requirements and facilitaꢀng the ꢀmely and accurate reporꢀng of adverse events and product
malfuncꢀons associated with medical devices.
3. Qualificaꢁons and Educaꢁon
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Bachelor's degree in a relevant scienꢀfic or healthcare discipline (e.g., biomedical engineering, nursing,
pharmacology) or equivalent experience.
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In-depth knowledge of medical device regulaꢀons and guidelines (e.g., FDA, EMA, ISO 13485).
Familiarity with adverse event reporꢀng requirements and processes.
Strong analyꢀcal and problem-solving skills.
Excellent aꢁenꢀon to detail and accuracy.
Effecꢀve communicaꢀon and interpersonal skills.
Ability to work independently and collaboraꢀvely in a team environment.
Proficiency in using soꢂware applicaꢀons for data management and reporꢀng.

Medical Device Reporting Analyst
GDOCOP-0006-01
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4. Responsibiliꢁes and Authoriꢁes
Regulatory Compliance:
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Stay up to date with the latest regulaꢀons and guidelines related to medical device reporꢀng, including those
issued by regulatory bodies such as the U.S. Food and Drug Administraꢀon (FDA) or European Medicines Agency
(EMA).
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Ensure compliance with applicable regulaꢀons and standards throughout the reporꢀng process.
Adverse Event Reporꢀng:
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Receive, review, and evaluate reports of adverse events or incidents associated with medical devices.
Conduct thorough invesꢀgaꢀons and gather relevant informaꢀon to determine reportability.
Assess the severity and impact of adverse events on paꢀents or users.
Determine if events meet the criteria for medical device reporꢀng and escalate as necessary.
Documentaꢀon and Record Keeping:
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Maintain accurate and complete documentaꢀon related to adverse event reports.
Ensure ꢀmely and appropriate entry of data into the designated reporꢀng system or database.
Monitor and track the progress of invesꢀgaꢀons, follow-up acꢀons, and report submissions.
Prepare and maintain necessary records, files, and documentaꢀon in accordance with regulatory requirements.
Reporꢀng and Communicaꢀon:
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Prepare and submit medical device reports (MDRs) or vigilance reports to regulatory authoriꢀes within the
prescribed ꢀmelines.
Collaborate with cross-funcꢀonal teams, including quality assurance, regulatory affairs, and medical affairs, to
gather relevant informaꢀon for reporꢀng purposes.
Communicate with regulatory authoriꢀes, customers, and internal stakeholders regarding medical device
reporꢀng maꢁers.
Provide guidance and support to internal teams on medical device reporꢀng requirements.

Medical Device Reporting Analyst
GDOCOP-0006-01
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Process Improvement and Training:
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Idenꢀfy areas for process improvement and implement correcꢀve acꢀons to enhance the medical device
reporꢀng process.
Develop and deliver training programs on medical device reporꢀng regulaꢀons, procedures, and best pracꢀces to
internal staff as needed.
Parꢀcipate in internal and external audits to ensure compliance and address any findings or observaꢀons related
to medical device reporꢀng.

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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.