Jay Pathak Email & Phone Number

Warsaw, Indiana, US

• Lead and manage regulatory activities for new and existing products, including medical devices, IVD, LDT, AI/ML Devices and SaMDs.
• Regulatory subject matter expert for IVD and LDT submissions for CD Diagnostics a Zimmer Biomet division.
• Manage current regulatory affairs including regulatory submission authoring and publishing electronic submissions.
• Manage regulatory affairs department, and provide guidance and direction to ensure the efficient and effective management of regulatory affairs activities.
• Formulate regulatory strategies, and effectively communicate associated risks to project teams and RA management, while outlining proposals for mitigating project risks.
• Establish Zimmer Biomet regulatory affairs policy and procedures, ensure compliance with the current regulatory procedures, and where needed, generate new and/or update procedures when new regulatory requirements are.

San Diego, California, US

• Subject matter expert & regulatory lead on new product (IVD and medical device) development.
• Manage current regulatory affairs for various medical devices and IVD Devices, including smart mobile applications, those utilizing SaMD, SiMD, AI/ML technologies, and digital health.
• Manage a team of Regulatory Affairs Specialists, and provide guidance and direction to ensure the efficient and effective management of regulatory affairs activities.
• Manage and delegate multiple regulatory projects based on business needs and priorities to ensure timely completion and compliance.
• Assist with regulatory submissions and approvals for medical devices and IVD devices utilizing advanced technologies.
• Lead the preparation and submission of regulatory filings for complex medical device products, implement global registration strategies, including EU MDR/ IVDR implementation, and interpret medical device regulations.

Brea, California, US

• Subject Matter Expert & core team lead on new product development.
• Lead regulatory filings for moderately to highly complex submissions & global registration/ implementation strategies
• Lead IVDR implementation.
• Regulatory lead & SME for site transfers.
• Interpret federal/state/international regulations related to BEC products, processes, and/or procedures, advise on the impact of regulations, & devise strategies for compliance.
• Support BEC business units (Diagnostics & Life Sciences) to develop, lead, & integrate the company's regulatory strategies and programs.

Salt Lake City, Utah, US

• Prepare EUA's, WHO pre-qualification, pre-market submissions & registrations of Medical Devices (IVD's) for submission to regulatory agencies.
• Collaborate with the maintenance of regulatory submissions & regulatory files related to 510(k), IDE /IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, &.
• Collaborate with Cross-functional teams to ensure high-quality regulatory filings, negotiate the resolution of agency questions, & secure market clearance &/or approval for new products &/or changes to existing products.
• Develop global regulatory strategies to ensure rapid & timely approval of devices & continued regulatory support of marketed devices & other products. Interact with regulatory agency personnel to expedite approval of.
• Assist in establishment registrations, product registrations (In Vitro Diagnostics), routine regulatory documents compilation, development, submission, and maintenance of worldwide regulatory filings. Apply for FDA.
• Collaborate with regulatory & compliance issues by providing independent regulatory guidance & support to product development teams for strategic planning, design & development, & post-market surveillance & compliance.

• Consult clients globally in Medical Devices, IVD sectors in activities concerned with complex submissions & approvals of products to govt. regulatory agencies.
• Assist in the preparation & maintenance of regulatory submissions & files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change.
• Consult with management personnel to establish & prepare appropriate regulatory filings, negotiate the resolution of agency questions, & secure market clearance &/or approval for new products &/or changes to existing.
• Develop world-wide regulatory strategies to ensure rapid & timely approval of devices & continued regulatory support of marketed devices & other products. Interact with regulatory agency personnel in order to expedite.
• Assist clients in establishment registrations (21 CFR 807), product registrations, routine regulatory documents compilation, development, submission, and maintenance of worldwide regulatory filings. Apply or write FDA.
• Provide guidance to clients regarding regulatory & compliance issues by providing independent regulatory guidance & support to product development teams for strategic planning, design & development, & post-market.

• Consulting clients in Dietary Supplement and Pharmaceutical industries for product Designs and Regulatory Compliance.
• Providing research and advice to clients on compliance with federal laws, FDA/USDA regulatory agency guidelines, FTC regulations, DSHEA Compliance, cGMP Readiness and EU Food Supplements Directive (FSD) as per EFSA.
• Researching government initiatives related to labeling and packaging for Clients as required.
• Helping Clients with proofreading of pharmaceutical package inserts and labels ensuring accuracy and consistency as per industry and government guidelines.
• Ensure labeling content, and product documentation is developed in accordance with FDA/ DSHEA and International regulatory requirements.
• Coordinate with the Labeling/Promotional group for the development of product labels and support of promotional materials.

• Assist clients with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs)
• Enter data as presented into the Complaint Management System and initiate Product Quality Complaint Investigation processing for internal and /or external manufactured products.
• Help investigate complaints to determine root cause, identify resolution, confirm correction, and respond to complainants as required.
• Create and support Non-Conforming Material Report (NCMR) and determine its escalation to a SCAR (Supplier Corrective Action Request).
• Assist and participate in CAPA investigations and enter all the information in the Compliance Management System.
• Assist in complaints regulatory reporting process (timely submissions, closure, health authority requests, etc.).

· Supervised, managed, coached and developed pharmacy team in providing pharmacy services.· Strategized and planned pharmacy business operations.· Analyzed and created business policies and procedures.· Created and managed compounding department per FDA Section 503A.

Woonsocket, RI, US

· Managed, coached and developed providing retail pharmacy teams for pharmacy services.· Designed and implemented, policies and procedures for pharmacy department operations.· Mentored the teams to achieve top performance metrics year after year.· Supervised retail pharmacy operations for multiple units.

Doctor Of Law - Jd, Law

Master Of Science In Regulatory Affairs, Regulatory Affairs

Master Of Science In Product Design & Manufacturing

Bachelor'S Of Pharmacy, Pharmacy