Anjana Hegde

Regulatory Affairs Specialist with 4+ years of experience supporting the lifecycle management of Class II and Class III cardiovascular medical devices and combination products. Expertise in FDA 510(k), EU MDR compliance, engineering change assessments, and global submissions. Proven track record of collaborating with cross-functional teams to author technical documentation, manage design controls, and maintain global product registrations.

Regulatory Operations Specialist (Contractor) at Abbott Vascular (2022-09 – 2024-01)

• Evaluated design, material, software, and manufacturing changes for Class II/III cardiovascular devices to determine global regulatory impacts (FDA, EU MDR).
• Coordinated with R&D, Quality, Manufacturing, and Clinical teams to compile technical documentation for global registrations across Europe, Canada, Australia, Brazil, and APAC.
• Reviewed and approved change orders, product labeling, and Instructions for Use (IFU) for regulatory compliance.
• Maintained DHF/DMR integrity and managed operational RA requirements including Declarations of Conformity, CFGs/COEs, Regulatory letter requirements (LoA, PoA, Authorizing License) and document legalization.
• Represented Regulatory Affairs on cross-functional teams, providing guidance on changing regulations and supporting internal, external, and MDSAP audits.
• Supported regulatory strategy for Class II and Class III cardiovascular devices
• Investigated nonconformities and determine mitigations, resolution plan (CAPA)
• Supported product registrations in Europe, Canada, Australia, Brazil and Asia-Pacific
• Maintained product registrations throughout the product lifecycle

Regulatory Affairs Associate II (Contractor) at AbbVie (2022-04 – 2022-09)

• Conducted Regulatory Intelligence and trend analysis for various drug products, biologics, and medical devices.
• Managed global Health Authority questions and Scientific Advice logs (US, EU, Japan, Canada) in the regulatory database to track CMC trends.
• Reviewed and cataloged global regulatory guidance documents specializing in Oncology, Cell & Gene Therapy, and CMC.

Executive – Regulatory Affairs at Micro Labs Limited (2018-02 – 2019-11)

• Compiled, published, and maintained regulatory filings, supporting documents, protocols, and specifications.
• Reviewed and approved product labeling, advertising, and promotional materials for strict regulatory compliance.

PG Diploma in Regulations for Biologics & Pharmaceutical Products – Indian Biological Sciences and Research Institute (2018)

MS in Chemistry – Bangalore University (2017)

BS in Chemistry, Botany, and Zoology – MES Degree College, Bangalore (2015)