Mahima Gupta

Regulatory Affairs & Compliance Specialist @Yukon Medical, Llc

US

Leading and authoring multiple 510(k)s, EU technical files, marketing licenses, Letter-to-files, technical dossiers for company\'s product portfolio.• Writing, reviewing, compiling, and submitting regulatory documentation, including, PSURs, postmarket surveillance documents, clinical evaluation protocols/reports, license amendments, BEPs, and more.• Managing global product registrations/licensing including the following- Determination of product classifications - Drafting of regulatory assessments and strategy - Identifying device pathway to registration - Interacting with various global regulatory entities as required - Completing required documentation to support registrations - Identifying and engaging with distribution vendors and regulatory consultants as required.• Liaising with local consultants for registering products in international markets such as Saudi Arabia, Japan, Singapore, Hong Kong, UAE, Kuwait, Israel, and more.• Assessing packaging, labeling, design, and process changes for regulatory impact and implementing them.• Supporting design control deliverables such as project plans, user needs, requirements, verification/validation plans/protocols/reports, trace matrixes, and more.• Generating risk evaluation and risk management documentation.• Generating and submitting change notices to Notified Body.• Addressing Notified Bodies and Authorized Representative documentation requests for new devices or changes to existing ones.• Assessing and documenting global complaints for reportability threshold and reporting them to the required entities.• Supporting notarization, legalization, and audit activities for regulatory documentation.• Performing annual device registration/listing and facility registration renewals.• Drafting/updating Work Instructions, Quality System Manuals, Procedures, and Quality Planning Documents.• Generating gap assessment documents for International Standards and determining action items.