Woburn, Massachusetts, United States
Quality & Regulatory professional with hands‑on experience in Quality Systems, CAPA, nonconformance investigations, risk management, change control, and audit support across pharmaceuticals and chemical manufacturing. Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, and GMP standards with expertise in documentation control, product quality review, statistical evaluation, and cross‑functional collaboration. Adept at driving root cause analysis, improving compliance, and supporting continuous improvement initiatives.
• Manage regulatory quality documentation and global compliance tracking using SAP. • Support audits (FDA/DEA/ISO) through documentation retrieval, evidence preparation & participation. Support investigations related to batch record deviations, including root cause analysis and CAPA development. • Coordinated with customers, sales teams, and managers to resolve documentation issues and expedite order clearance processes. • Conduct analysis of regulated items and compliance transactions ensuring adherence to global requirements. • Prepared product end-use letters and TSCA declarations to ensure compliance during the import clearance process. • Reviewed inbound and outbound shipments for import/export compliance, including export licenses, duty drawback, FDA clearance, harmonized tariff codes, and FCC regulations. Prepare and review regulatory assessments for licensing, registrations, and customer communication.
Developed the regulatory strategy for medical device/in-vitro diagnostics clearance and marketing in the United States and EU Draft, edit, and format NDA and 510(k) content for combination products, covering device components. • Created and delivered content to support the implementation and sustainability of the Quality Management System. Reviewed quality system documents and served as an interface between site resources to implement and maintain key systems in compliance with regulations. • Presented FDA 510k submission process for medical device clearance in the US and Canada. • Collaborated with product development teams to ensure that designs, procedures, and project outcomes meet quality standards. • Generated and implemented Quality System Regulation (QSR) to ensure compliance with regulatory requirements.
• Applied GMP principles to pharmaceutical manufacturing processes, ensuring compliance and quality standards. • Worked on providing scientific evidence to support Good Clinical Practice (GCP) of product and its safety. • Reviewed Corrective and Preventive Actions (CAPA) documents, SOPs, deviations including follow ups and reporting. • Reviewed various quality batches, and evaluated Internal Quality SOPs, also ensuring quality execution in terms of detailing as per the guidelines. • Performed monthly internal and external audits of vendors and suppliers. Reviewed all the regulatory, audit and Quality related documentation as per the GMP. • Performed Good Documentation Practices using Quality Management System (Veeva Vault).
• Collaborated with cross-functional teams, including quality, to compile and review necessary documentation for regulatory submissions. • Developed the FDA pre-submission request package, including regulatory pathways, pre-clinical, and clinical pathways. • Completed in-depth research and analysis to back up regulatory filings and stay current on regulatory needs. • Assisted in the maintenance of regulatory files and ensured adherence to regulatory standards. • Facilitated regulatory submissions by working with quality assurance and clinical teams to gather data and documentation. • Utilized exceptional interpersonal skills to communicate effectively and foster positive working relationships with internal and external stakeholders.