Rohan Pawar
Boston,MA
Summary
Regulatory Affairs professional with a Master's degree and over 2 years of experience in medical device compliance, specializing in the preparation and submission of 510(k)s, IDEs, and international submissions. Proven track record in ensuring adherence to FDA, EU MDR, ISO, and global regulations through roles at CVS-Aetna, Conformis, and Zoll Medical Corporation. Adept at collaborating with cross-functional teams to develop and execute regulatory strategies, technical documentation, and process improvements that enhance operational efficiency and quality standards.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Healthcare Analyst
CVS-Aetna
09.2023 - 05.2024
- Enhanced healthcare quality and reduced costs through insightful analysis of disparate data sources using the Dynamo Case Tracker
- Developed and executed CAPAs, initiating process improvements that reduced error rates by 20% and bolstered quality standards, enhancing operational efficiency
- Collaborated with internal teams implementing program improvements and executing precise management plans for product, clinical, and financial objectives
- Led project to develop Run books and SOPs for existing applications and processes to enhance operational efficiency.
Regulatory Affairs Co-ordinator (Capstone Project)
Conformis
03.2023 - 04.2023
- Led a 4-month capstone project to create an in-depth PowerPoint presentation on MDSAP.
- Assisted in the development of standardized procedures and protocols for initiating and tracking CAPA activities, facilitating timely resolution of non-conformances, and enhancing quality management processes.
- Developed a detailed white paper on MDSAP audit strategy, integrating best practices and compliance guidelines.
- Coordinated extensively with stakeholders and conducted thorough research for the white paper.
Regulatory Affairs Co-op
Zoll Medical Corporation
07.2022 - 12.2022
- Led initiatives for regulatory compliance, overseeing adherence to QSR 820, ISO 13485, and ISO 14971
- Assisted 510(k) document submissions and promptly addressed FDA inquiries, ensuring timely clearance
- Addressed labeling issues through effective Corrective and Preventive Action (CAPA) implementation for class I, II, and, III devices
- Led the implementation of design change controls for Class II medical devices by ISO 13485
- Prepared and reviewed technical dossiers such as CE technical files to maintain compliance with regulatory standards
- Independently prepared STEDs, showcasing meticulous attention to detail and regulatory expertise
- Actively engaged in internal audit processes, contributing to evaluating regulatory compliance and quality management systems.
Post-Market Surveillance Analyst
LabCorp Drug Development
11.2020 - 08.2021
- Analyzed quality data and reviewed documents for ICSRs from cross-functional teams
- Provided audit support for internal process audits and trained junior colleagues on Pharmacovigilance Processes
- Teamed up with cross-functional teams to enhance post-market surveillance strategies and assisted with safety activities
- Tracked quality metrics, project deviations, and inspections generated charts, and presented them to the team while collaborating with the FQA team.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA06.2023
Bachelor of Science - Pharmacy
Sinhagad Institute of Pharmacy
Pune, India07.2020
Skills
- Regulatory: Proficient with USFDA, EUMDR, IVDR 2017/476 Pharmacovigilance Design Control ICH Guidelines Clinical Development Plan QMS MDSAP CAPA Internal Audits Verification and Validation Plan Regulatory Strategy Technical Writing International Submissions
- Technical Skills: Microsoft Office Suite Agile PLM RegDesk SharePoint Adobe Mondaycom SAP
- Soft Skills: Efficient verbal and written communication Collaborative Critical Thinking Project Management Attention to Detail Good Organization Skills Problem-Solving Skills Leadership
Certification
- IVDR 2017/746 Regulatory Affairs: Learn EU Compliance
- Six Sigma: White Belt
- Benefit-Risk Assessment Training and Role of Artificial Intelligence in Pharmacovigilance (LabCorp)
- Internal Audit on Medical Device QMS ISO 13485: 2016
- Project Management: Healthcare Projects
Projects
Northeastern University, Boston, MA, 09/21 - 06/23
- Developed a Regulatory Strategy for the QOCA Portable ECG Monitor.
- Drafted a Regulatory Strategy for a PTA Balloon Catheter coated with a chemotherapy drug.
- Engineered Regulatory Strategy for Software as a Medical Device, Cardio-Ace ECG App.
Timeline
Healthcare Analyst
CVS-Aetna
09.2023 - 05.2024
Regulatory Affairs Co-ordinator (Capstone Project)
Conformis
03.2023 - 04.2023
Regulatory Affairs Co-op
Zoll Medical Corporation
07.2022 - 12.2022
Post-Market Surveillance Analyst
LabCorp Drug Development
11.2020 - 08.2021
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Science - Pharmacy
Sinhagad Institute of Pharmacy
- IVDR 2017/746 Regulatory Affairs: Learn EU Compliance
- Six Sigma: White Belt
- Benefit-Risk Assessment Training and Role of Artificial Intelligence in Pharmacovigilance (LabCorp)
- Internal Audit on Medical Device QMS ISO 13485: 2016
- Project Management: Healthcare Projects
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