Ishrar Akhtar

About Ishrar Akhtar

With a strong focus on medical device safety and post-market surveillance, I am dedicated to ensuring compliance with global regulations and advancing best practices in Materiovigilance and Clinical Data Management. My expertise lies in regulatory compliance, complaint handling, and product investigation, with hands-on experience in adhering to FDA, EU-MDR, and ISO standards. I am passionate about staying updated with the latest advancements in the field, leveraging my skills to drive product safety and quality. Whether it’s processing complex cases, conducting thorough investigations, or collaborating with cross-functional teams, I strive to deliver results that meet the highest regulatory and organizational standards. Let’s connect to discuss how we can work together to enhance medical device safety and regulatory excellence!

Experience

1. Regulatory Affairs Specialist

   Cognizant

   Jul 2022 — Present · Kolkata, IN

   Case Processing & Triaging them to Reportable/Non-Reportable issue.Ensuring regulatory compliance and Global Case Submission to USFDA(EU-MDR), Health Canada (MPR), and other regulatory affairs (MIR & MDI) within TAT.Appropriate PMA/510k number and narrative writing as per the caseinformation and investigation in the reports.Complaint Handling and product investigation of medical devices.Identify missing clinically relevant details from case report and initiateits collection process by preparing follow-up requests as necessary.Prepare and submit all MEDWATCH/User Reports to USFDA/Affiliatesin compliance with regulations, guidelines under the requiredtimeframe.Good understanding of post marketing surveillance, ICH, andregulations related to medical device safety.Collaborate with cross functional teams to gather and analyze data andprepare comprehensive reports to support product safety assessments.Ensure scientific rigor through accurate, complete and consistent dataentry including Adverse event/Non-Adverse event as per case receivedfrom numerous sources.Receive and review information on adverse/Non-adverse events,perform initial checks and check databases to avoid duplicate entries.Converting complex data into an user-friendly format.Sustaining a magnificent knowledge of case processing and guidelines asper client’s procedure.Review processed cases to validate their accuracy, consistency andcompliance with procedural guidelines.Knowledge of FDA and EU requirements, ICH regulations andadherence to ISO standards as per the regulatory documents necessities.Contribute to the development and implementation of SOPs ensuring compliance with applicable regulations and guidelines.

Education

• Oriental Group of Institutes

  Bachelor of Pharmacy - BPharm