Rohan Pawar Email & Phone Number

Norfolk, 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.

Improved 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

Billerica, Massachusetts, United States

Led 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.

Boston, Massachusetts, United States

Chelmsford, Massachusetts, United States

I 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.

Pune, Maharashtra, India

I 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).

Maharashtra, India

I 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

Ms Regulatory Affairs, Regulatory Affairs

Bachelor Of Pharmacy - Bpharm, Pharmacy

Hsc, Science