Regulatory Expert Global Medical Device Compliance

Summary

RAC Certified Regulatory Expert with a proven track record of navigating complex global compliance landscapes for medical devices. I specialize in the end-to-end lifecycle of medical technology, from initial New Product Development (NPD) to long-term sustaining license maintenance.

Core Competencies

● Global Market Access: Extensive experience spearheading submissions across major markets including the US (FDA), EU (MDR/IVDR), and Canada (Health Canada), as well as emerging markets in APAC, EMEA, and LATAM.

● Technical Specialization: Deep expertise in the intersection of hardware and software, with specific mastery of SiMD

(Software in a Medical Device) guidance and integrated system compliance.

● Strategic Lifecycle Management: Skilled in managing the regulatory hurdles of both breakthrough innovations and the ongoing maintenance of existing product portfolios. Core Competencies

● Preparing Technical Documents for EU MDD and MDR submissions - Drafted EU Technical documents, Change Notifications

● Experience with FDA submissions - PMA supplements, Annual reports, 510 (k)

● Experience handling confidential and sensitive documents

● Product Change Assessments for US, EU and Canada

● Ability to handle multiple projects at the same time and ensure that the deadlines are met ● Strong Attention to Detail and excellent interpersonal skills

● Ability to work well in a team environment or independently

● Exceptionally organizational and meticulous

● Exceptional interpersonal and communication skills Professional Experience

Quality and Regulatory Affairs Specialist

Amazon Lab 126 March 2025 - Present

Spearheading the end-to-end regulatory deliverables and quality compliance for high-priority pipeline products and emerging medical technologies. As the primary liaison between R&D, Engineering, and Biocompatibility SMEs, I'm responsible for comprehensive submission strategies that translate complex technical data and reports into robust, FDA-ready documentation. By directing cross-functional work streams and ensuring rigorous adherence to FDA 21 CFR standards and QMS protocols, I'm responsible to maintain the integrity of all regulatory filings to ensure seamless market entry and expedited product clearance. Regulatory Affairs Specialist II January 2023 - Present Abbott

My current role at Abbott is to support the US, EU submission activities for Cardiovascular products (US Class II and ClassIII) while also working with global affiliates for internationals submissions

● Drafting and submitting PMA Supplements and PMA Annual reports (US)

● Drafting Letters to File and Change Notifications to EU notified bodies

● Working with EU MDR technical documentation

● Periodic update of technical documentation - Technical Files, IFUs, ERC, GSPR

● Working on cumulative change assessments for 510(k)s (US)

● Preparing Regulatory Impact Assessments for Product changes, reviewing and approving Change Orders on document system

● New Product submissions and annual reports and on-going license maintenance and renewals for Health Canada

● Working with international regulatory affiliates for regulatory assessments and product releases Regulatory Affairs Specialist August 2021 – January 2023 Shockwave Medical

My role at shockwave Medical involved working on the US, EU submissions for Cardiovascular products ( both new products as well as sustaining license maintenance)

● Worked on IDE submissions - Drafted the content, Attended FDA meetings, worked on responding to FDA queries

● Worked on Pre-submissions to US FDA for new cardiovascular products under development ● Submitted a PMA Real-Time supplement to FDA for a significant product change ● Worked on MDD and MDR technical documentation - Technical files, ERC (Annual updates and maintenance) and GSPR (MDR)

● Supported FDA submissions - 510 (k), PMA - responded to FDA and BSI queries ● Prepared Regulatory Impact Assessments for Product changes (NPDs and commercially approved products) - Drafted LTFs and Change Notifications

● Performed periodic gap assessment to stay compliant with standards

● Periodically updated technical documentation - Annual Technical File updates, IFUs, ERC etc. ● Attended Regulatory webinars and workshops and presented the excerpts to the regulatory team

** Attended RAPS convergence 2022 and presented the excerpts to the regulatory teams ** Attended 510 K webinar by ADVAMED and presented the excerpts to the regulatory team Regulatory Affairs Specialist May 2019 – August 2021 Johnson & Johnson Vision

Worked in the Global Regulatory Operations team - supported the registration and re-registration of the ophthalmic surgical products. My responsibilities include the following -

● Supported Global RA teams in procuring the documents and preparing dossiers for health authority submissions for new product registrations and renewals

● Ordered Certificates to Foreign Government on US FDA website.

● Performed regular document searches (Technical Files, DOCs, IFUs, Labels etc.) ● Supported in international product submissions - China and Canada

● Supported remote audits

● Worked closely with QA, R&D teams in fulfilling the requests from global/ regional RA teams ● Regular communication with the third-party manufacturers for Certificates of Analysis/ Conformity ● Notarization, shipping the documents for apostilling, legalization

University of New South Wales Jan 2013 - June 2013 Research Assistant Worked in a Hematology lab and supported a project on Acute Myeloid Leukemia. My project involved the following techniques

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• RNA Extraction

• Cell Culture Maintenance ( Rat and human Bone marrow Cells)

• Transfection

• Animal handing ( Mice)

University of Sydney Jul 2012 - Dec 2012

Research Assistant, Cardiology

As a part of the Cardiac Technology Center group at Royal North Shore Hospital, Sydney, I was Involved in a project on Aortic stiffness. My work involved the following:

● Cell culture maintenance – Worked with rat bone marrow stem cells to understand the effect of Pim-1 Kinase on their cardio-protective effectiveness.

● Preparation of consumables for use in cardiovascular experiments on sheep such as IV fluids, drugs, IV lines, disposable catheters, and guide wires and sheaths.

● General lab maintenance duties.

Joslin Diabetes Center, Boston Mar 2011-Dec 2011 Research Assistant, Immunology My research project was to understand various developmental stages and differentiation of T-lymphocytes in vitro and the factors driving their differentiation.

● Worked with research protocols and SOPs

● Lab record maintenance and GLP compliance

● Compliance with animal Ethics department for handling mice in an experimental setting ● Performed experiments on mice using different techniques like – Mammalian cell culture, animal ● Animal Handling – Performed surgeries on Mice

● PCR, FACS etc.

● Analyzing and documenting experimental results

Beth Israel Deaconess Medical Center May 2010 – August 2010 Intern, Immunology and Oncology Research Worked in an immunology lab and my responsibilities included the following –

● Animal Handling – Weaning Mice

● Genotyping

● DNA and RNA isolation

● Western blotting and co-immuno precipitation

Education

● RAPS Regulatory Affairs Certificate Program - RAC, Medical Devices - In Progress Estimated completion Dec 2024

● M.S. in Drug Regulatory Affairs - Northeastern University, Boston USA - GPA 3.7 ● Bachelor’s in Pharmacy – Osmania University, India - GPA - 3.5

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