Rohan Pawar Email and Phone Number
🔹 Regulatory Affairs Specialist | Post Market Surveillance Analyst | Healthcare Analyst 🔹Dedicated Regulatory Affairs Specialist with a robust background in pharmacy and a Master's in Regulatory Affairs from Northeastern University. Proven expertise in devising and executing regulatory strategies to ensure compliance with USFDA, EU MDR, and Health Canada regulations. Skilled in guiding product submissions, leading internal audits, and addressing labeling issues across diverse medical device and pharmaceutical environments. Currently leveraging analytical prowess as a Healthcare Analyst at CVS-Aetna, driving healthcare quality enhancement and cost reduction through data-driven insights.🔹 Key Skills: Regulatory Compliance | Product Lifecycle Management | Quality Management Systems | Regulatory Writing | Cross-Functional Collaboration | Clinical Development | Project Management | Pharmacovigilance | International Regulatory Submissions.
Instant Systems Inc.
View- Website:
- instantsystems.com
- Employees:
- 19
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Regulatory Affairs SpecialistInstant Systems Inc. Aug 2024 - PresentNorfolk, Virginia, United States• Leading 510(k) premarket submissions for Class II medical devices and maintaining compliance with FDA and EU MDR requirements.• Enhancing QMS to meet regulatory standards, supporting risk management assessments, FMEA, and cross-functional compliance efforts.• Collaborating with laboratories for biocompatibility evaluations and performance testing.• Managing product labeling, UDI system implementation, and updating the GUDID database.• Coordinating with FDA, EU Notified Bodies, and Competent Authorities on pre-submission meetings and product development inquiries.• Developing and updating Device Master Record, Design History File, and relevant SOPs and training key personnel to align with industry standards and regulatory updates.
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Healthcare AnalystAetna, A Cvs Health Company Nov 2023 - Aug 2024Improved healthcare quality and reduced costs by leveraging data analysis with the Dynamo Case Tracker. Developed and implemented corrective action plans (CAPAs) leading to a 20% error rate reduction and enhanced quality standards. Streamlined operations by creating Runbooks and SOPs for applications and processes. Acted as a liaison between internal stakeholders and technical support regarding healthcare complaints, ensuring excellent customer service for all quality-related inquiries -
Regulatory Affairs Coordinator (Capstone Project)Conformis Mar 2023 - Jun 2023Billerica, Massachusetts, United StatesLed a 3-month project to develop a comprehensive PowerPoint presentation offering an in-depth overview of the Medical Device Single Audit Program (MDSAP), covering key aspects and requirements.Actively worked on creating a detailed white paper outlining an effective strategy for conducting MDSAP audits, incorporating best practices and compliance guidelines, with extensive research and collaboration with stakeholders. -
Rso ProctorNortheastern University Oct 2021 - May 2023Boston, Massachusetts, United States -
Regulatory Affairs CoopZoll Medical Corporation Jul 2022 - Dec 2022Chelmsford, Massachusetts, United StatesI have played a pivotal role in optimizing regulatory operations by enhancing the accessibility and efficiency of crucial files such as SOPs, 510k, PMA, and QMS through streamlined document retrieval processes. My contributions include assisting in comprehensive regulatory submissions, ensuring compliance, and facilitating smooth CE Technical file maintenance. I have efficiently managed Engineering Change Order (ECO) and Engineering Change Request (ECR) processes, minimizing errors and ensuring adherence to product compliance. Additionally, I have been instrumental in label development, compliance reviews, and change control submissions. Leveraging RegDesk, I've proactively tracked regulatory changes, mitigating risks. Through active participation in internal audits, I've collaboratively identified and rectified compliance gaps, cementing a strong regulatory framework for the organization. -
Safety Science Analyst/ Post-Market Surveillance AnalystLabcorp Drug Developement. Nov 2020 - Aug 2021Pune, Maharashtra, IndiaI played a pivotal role in pharmacovigilance and safety activities within cross-functional teams, focusing on J&J Covid-19 Vaccine and Non-Medicated Cosmetics. I meticulously analyzed quality data and conducted checks on Individual Case Safety Reports (ICSRs), ensuring accuracy before reporting. Additionally, I contributed to safety initiatives by tracking performance metrics, designing templates, and updating Quality Control (QC) dashboards for the triage team. During internal process audits, I provided comprehensive support by elucidating departmental Standard Operating Procedures (SOPs) about case triage, medical coding, follow-up, case processing, and peer review of ICSRs to auditors. Furthermore, I played a key role in knowledge transfer, mentoring junior colleagues on pharmacovigilance processes, MedDRA, quality review, and pharmacovigilance agreements (PVAs). -
Summer InternCure Medicines India Private Limited Jun 2018 - Jul 2018Maharashtra, IndiaI ensured compliance with current Good Manufacturing Practices (cGMP) for tablets, capsules, and liquid dosage forms, facilitating timely batch release. My responsibilities included testing raw materials and finished drugs in the quality control department and overseeing the quality assurance process for batch approval. I collaborated across departments to uphold calibration records, manage GMP operations, and maintain equipment logs
Rohan Pawar Skills
Rohan Pawar Education Details
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Regulatory Affairs
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Sinhgad Institute Of PharmacyPharmacy -
Mit Jr. College, Pune 38Science
Frequently Asked Questions about Rohan Pawar
What company does Rohan Pawar work for?
Rohan Pawar works for Instant Systems Inc.
What is Rohan Pawar's role at the current company?
Rohan Pawar's current role is Regulatory Affairs Specialist | Streamlining Operations, Ensuring Compliance.
What schools did Rohan Pawar attend?
Rohan Pawar attended Northeastern University, Sinhgad Institute Of Pharmacy, Mit Jr. College, Pune 38.
What skills is Rohan Pawar known for?
Rohan Pawar has skills like Leadership, Arisg, Industrial Safety, Regulatory Operations, Abacus, Communication, Regulatory Affairs, International Standards, Pharmacovigilance, Mdrs, Microsoft Office, Microsoft Word.
Who are Rohan Pawar's colleagues?
Rohan Pawar's colleagues are Noor Arora, Chris Pates, David Wickre, Matthew Orlando, Lara Matela, Aidan Jenson, Ginger D’angelo.
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Rohan Pawar
Denver Metropolitan Area3cognizant.com, gmail.com, wipro.com1 +447845XXXXXX
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Rohan Pawar
Process Engineer - Operations | Chemical Engineering Expertise| Seeking Full-Time Engineering Job | Graduating In December 2024San Jose, Ca
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