Regulatory Affairs Manager

• Aug 2021 - Present

Principal Regulatory Affairs Specialist

• Jun 2021 - Aug 2021

- Pre-Submission to FDA- Led FDA and BSI Teleconference on new Product Development Project

Senior Regulatory Affairs Specialist

• Jul 2016 - Jun 2021

- MDSAP Audit (Front room and backroom support) and Internal Audits- Pre-submission to FDA- CAPA lead- Panel Track PMA Supplement for Indication Expansion- Clinical Strategy and Review Package (CSRP) Submission to Notified Body- Multiple 30 Day PMA Supplements to FDA- Global Strategy roll out for new indications - China submission to NMPA and manufacturing transfer to China- LBM (Labor Burden and Material) reduction by implementing innovative eIFU strategies - Review of Advertisement and Promotional materials- Lead for Latin America, Indian Sub-continent, ANZ and ASEAN registrations for Aortic products- Led a one-day Negotiation training for regulatory team of over 75+ people- Program lead for in-house regulatory training comprising of 75+ people- Initiated a Finance Club chapter to enhance business acumen of the team

Finance Club - Common Cents

• Jun 2019 - Apr 2021

- Started a finance club for the regulatory team to build financial acumen - Presented on topics like P/E ratio, ESP, dividends, Balance sheet, Income statement, Cashflow, Capital budgeting techniques (NPV, IRR)- Invited guest speakers (eg. VP Finance) to cover topics like interest rate, Mutual funds, ETF, 401k, IRA, etc.

Core Team Lead (PMO) Rotation

• Oct 2017 - Feb 2019

-Program Lead for Heli-FX EndoAnchor system and Sentrant Introducer Sheath core team. -Led a cross functional team for design changes and indication expansion.-Managing program goals, risks, budget, IMS (Integrated Master Schedule) using Microsoft Project, program deliverables and product inventory.

Pipeline Marketing Rotation

• Feb 2018 - May 2018

Did a 3 month rotation in pipeline marketing. Assisted in analyzing data from Strat plan and Voice of Customer (VoC) to build market models.

Regulatory Affairs Specialist

• Nov 2014 - Jun 2016

Design DossiersPMA Supplements Post Approval Study Report (PASR)STED Creation and MaintenanceElectronic Instruction for Use (eIFU) Strategy and implementationGlobal Regulatory Submission Strategy and Implementation

Regulatory Affairs Specialist

• Mar 2014 - Oct 2014

Worked on moderate to complex submissions including high-risk Class II devices. Worked concurrently on three product development projects (PDP) for new Class II medical devices, eventually requiring pre-market notifications [510(K)].Authored two 510(K)'s for Urology and Neurology division at FDA.Re-strategize the regulatory pathway based on evolving FDA regulations for a medical device via Letter-to-File as compared to a 510(K) submission thus assisting the marketing team to complete a .5 million US dollar tender with a hospitalWorked on strategies to align 510(K) submission process within Karl Storz Endoscopy (510(k) Module). Identified a potential problem in the Product Change Notification (PCN) system, worked with cross-functional groups on a solution including creating new flowcharts, forms and revising SOPs.Assisted in building the Regulatory Affairs department from 2 to 4 RA Professionals.

Regulatory Submission Specialist

• Apr 2013 - Mar 2014

Authored and received successful clearance for Flexible CMOS Video-Cysto-Urethroscope (Class II medical device).Responsible for training engineering and complaint-handling group on Risk-Analysis process (EN ISO 14971:2012)RABQSA ISO 13485 Internal Auditor Certification - January 2014

Regulatory Affairs Associate

• Mar 2012 - Apr 2013

Authored a traditional 510(k) for Power LED 175 (Class II medical device) and received a clearance for the same without any deficiencies.Received successful clearance on CMOS Video Rhino-Laryngoscope system (Class II medical device) by responding to additional information requested by FDAProject Lead for Karl Storz new global product development project. As a core team member on this project I had to participate in/perform following activities:-Creating a Regulatory Strategy (Regulatory Design & Development Plan) for launching the medical device in US and EU. -Participate in Risk Management activities. Participated in team discussions on reprocessing techniques for Medical DevicesDeveloped and maintained tools for tracking global submission/approval status and submission requirements for the Fast Track submissions in Mexico. Communicate with regulatory agencies in case of ‘Prevention’ for a submission as well as communicate with our in-country affiliates and distributors to address questions on specific submissions.Lead a project to streamline the process for licensing Class II medical devices in CanadaResponsible for FDA annual registrations & device listings. Implemented ‘CDRH Export Certificate Application & Tracking System’ (CECATS) system to replace the manual application

Quailty Engineer

• Jan 2011 - Mar 2012

Dentium USA is a world class manufacturer of dental implant systems and distributor of a large selection of dental instruments, lab components and grafting materialsEvaluated incoming product complaints and analyzed Dentium USA products to determine MDR eligibility. Investigated specific events by contacting internal resources, Dentium USA field personnel and physicians/customers as appropriate. Ensured that the complaint files were complete and maintained properly to satisfactorily meet Quality System Regulations(21 CFR 820) requirements and to comply with FDA requirements. Initiated, completed and submitted MedWatch reports for timely submission to the FDA. Knowledge of 21 CFR Part 820, Quality System Regulations. Knowledge of 21 CFR Part 803, Medical Device Reporting. Applied to FDA for Annual Summary Reporting (ASR). Responsible to perform receiving, in-process and final Inspection activities. Evaluate non-conforming products and initiate a CAPA if necessary.Responsible for documentation of Shop orders, drafting new as well as making changes to existing Standard Operating Procedures and Device History Records as well as collaborating with the Operations and Manufacturing Department to ensure compliance to the new procedures. Worked with the core Product Development team to provide Regulatory guidance and inputs so as to come to a most effective Regulatory Strategy for the business. Initiated Engineering Change Notifications (ECN) and their closures. Evaluate process changes and maintain the controlled documentsProvided front room support on FDA Audit, TUV Audit for ISO and CE Certification as well as internal audits. Also reviewed Technical Files.Also responsible for the quality assurance associated with labeling and handling various approved Suppliers. In charge of implementing various audit findings and continuous quality system improvement.

Regulatory Affairs Intern

• Sep 2010 - Jan 2011

Worked under direct supervision of the president of the company for an Ophthalmic Device manufacturer (OVD-Class III device).Responsible for developing regulatory strategies for clients of the company.Assisted the president in designing an Informed consent Form (English and Foreign Language), clinical protocol, etc all in anticipation of an IDE filing in accordance with 21 CFR 50. Searched FDA database for approved IRBs in a non-USA site and evaluated the an IRB for an international client. Interacted with the IRB and finalized all the formalities.Audited the clients (International Medical Device Inc.) manufacturing facility and suggested necessary changes in accordance with 21 CFR 820.

Technological Enhanced Learning Coordinator

• Sep 2009 - Sep 2010

Worked as a technical assistant in supporting the school's presentation system. Managing inventory and categorizing documents and equipments. In-charge of developing SOP (Standard operating Protocols) for systems used to maintain the presentation system.Project In-charge for distance education enhancement, Making e-learning easy by using Adobe Presenter. Worked as a technical assistant in supporting the school's presentation system. Managing inventory and categorizing documents and equipments. In-charge of developing SOP (Standard operating Protocols) for systems used to maintain the presentation system.Project In-charge for distance education enhancement, Making e-learning easy by using Adobe Presenter.

Intern, Biomedical Engineer

• Jul 2008 - Nov 2008

Processed at administrative department in handling invoices, requisitions, PO and PMC/AMC filing. Prepared spreadsheets for maintaining inventory.Developed experience in installation, calibration and maintenance skills of medical equipment. Accompanied various company engineers in maintenance and repair of various Medical Devices.Conducted a detailed study of Gamma Camera, Defibrillator and Electrosurgical Machines.Team Leader for a project on ‘Role of Biomedical Department in emerging Hospitals’ and it dealt with capacity optimization, increasing human productivity and reducing time errors.