Regulatory Affairs Medical Device

Kamal R Shah

Parsippany, NJ *****

973-***-**** linkedin.com/in/kamal-shah-69860214 *************@*****.***

SUMMARY

Detail-oriented and experienced Regulatory Affairs professional with over 9 years of experience in preparing, reviewing, and submitting regulatory filings for pharmaceutical products. Proven ability to navigate the complexities of FDA regulations, manage project risks, and facilitate efficient regulatory processes. Seeking to leverage my expertise in regulatory affairs, compliance, and project management as Manager, Regulatory Affairs

PROFESSIONAL EXPERIENCE

Stryker May 2025 to Present

Senior Regulatory Science Specialist

•Support manufacturing of orthopedic medical device products pertaining to the sterilization and cleanliness of the devices.

•Assess the impact of manufacturing related changes on the sterilization and cleanliness attributes of finished medical device products.

•Responsible for cGMP/cGDP, standard laboratory techniques (i.e. USP and ISO based testing methods) and safety procedures (i.e. OSHA).

•Performs QA/QC duties,scientific concepts, specific laboratory protocols,measures and terminology.

•Author and execute protocols and final reports to assess impact of manufacturing related changes against cleanliness requirements for impacted medical devices.

•Provide analysis and evaluation of materials and products at all stages of development process.

•Execution microbiological and chemistry testing both internally and externally.

•Communicate and collaborate with project owners to obtain all necessary information for assessment.

•Entail communication with internal operations and/or external suppliers.

•Conducts work in compliance with cGMP/cGDP, safety and regulatory requirements.

•Responsible for medical devices, concepts of manufacturing equipment, and/or sterilization.

•Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner.

•Support and provide guidance to suppliers for the SICR for change request.

Guide point Online Platform Feb 2024 to April 2025

Senior QA/Regulatory Affairs Compliance

•Developed strategies to respond to FDA deficiency notices, providing clear and concise solutions to address regulatory concerns.

•Provide expertise for QA and Regulatory Compliance based on client’s requirements.

•Expertise for CAPA and non confirmance and prepared documented evidence for regulatory audits.

Bristol-Myers Squibb,Summit West,NJ May 2019 to Jan 2024

Senior QA/Regulatory Affairs Compliance

•Preparing and submitting regulatory filings, including Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs), 505(b)(2) applications, as well as handling Amendments, Supplements, and Annual Reports, includes ensuring compliance with FDA requirements, preparing documentation for review, and managing the submission process to support product approval and market maintenance.

•Suggest process improvements for quality and safety of the product by reducing errors and defects,adapt regulations,Improving employee training and implementing CAPA.

•Reviewed and approved change notices, specifications, batch records, and standard test methods to ensure compliance with cGMP standards.

•Led the preparation for meetings with the FDA, including defining questions, preparing supporting information, and managing responses for complex projects.

•Preparing document packages(Regulatory Dossier) for regulatory submissions demonstrate a product’s safety,quality, and efficacy to regulatory authorities to ensure compliance with regulations.

•Responsible for ensuring the regulatory compliance and verification of CMC and injectable product documentation through workflows in the company’s Electronic Document Management System (EDMS) and also involves managing the creation, review, approval, and final storage of regulated documents.

•Support of dispositioning product for compliance with client directives,procedures and regulatory standards.

•Responsible for quality expertise and oversight of the batch disposition process to deliver high-quality documentation as per FDA and ICH guidelines in highlight regulated environment and to follow GDPs.

•Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.

•Prepares,revises,routes,reviews and approves GMP documents in support of quality assurance cell therapy Operations using strong organizational skills and critical thinking skills.

•Produces and reviews high-quality documents that meet applicable standards and are appropriate for their intended audience as per FDA/EMA regulatory requirements applicable to biologics,pharmaceuticals.

•Work in a highly regulated environment to follow GDP,GMP electronic documentation systems.

•Work in a collaborative team environment,train others,mentor associates and set priorities for the group.

•Strong organizational skills and critical thinking skills helps authors and revises GMP documents.

•Monitored and maintained awareness of all regulatory activities on assigned projects, minimizing regulatory issues and preventing unnecessary delays.

•Managing the development of documents through EDMS for the execution of change controls as needed.

•Knowledge of regulatory submissions of series of documents to a health authority as evidence of compliance.

•Access the source system during HA inspections,internal audits,data integrity check,data governance.

•Follow guidelines of CDER(center for drug evaluation and research),MHRA(medicines and health care products Regulatory agency),FDA,EMA(european medicine agency),GVP(good PV practice)for european union, also good practice for data management and Integrity in regulated GMP/GDP environment.

•Responsible for the Module 3 regulatory submission for a pharmaceutical product.

•Ensure comprehensively document the "Chemistry, Manufacturing, and Controls (CMC)" aspects of the drug, includes detailed information about the drug substance, drug product, manufacturing processes, quality control methods, and analytical specifications.

•Contributed to the development and implementation of policies ensuring ongoing compliance of Regulatory Affairs activities.

•Developed strategies to respond to FDA deficiency notices, providing clear and concise solutions to address regulatory concerns.

•Actively involved in the planning and coordination of Pre-ANDA and Post-Approval meetings with the FDA, ensuring all necessary documentation and questions were addressed.

•Managed deficiency response meetings by defining scope, deliverables, and response strategies to address regulatory issues.

•Collaborated with cross-functional teams in the development of both complex and non-complex generics across various dosage forms, including combination products.

•Ensure documentation should outlined in the Common Technical Document (CTD) guidelines, all relevant data and supporting documentation are included to demonstrate the product's quality and consistency.

•Worked with the FDA using the CDER NextGen Portal for submission of FDA communications and managed change control through TrackWise Harmony.

•Collaborated with cross-functional teams to ensure timely and accurate regulatory submissions for pharmaceutical products.

Novartis,EastHanover,NJ Jan 2019 to May 2019 Senior Technical Writer(QA/Regulatory),Cell&GeneTherapy

•Responsible for standards and GXP,CV (IQ/OQ,PQ),regulatory compliance 21 CFR Part 11,CFR 820,Part 1271,Part 211,29 CFR 1904,29 CFR 1910,ISO13485,14001,9000,9001 to meet the requirements of regulatory as per IT-pharma medical device quality and compliance.

•Prepared, reviewed, and submitted regulatory filings including ANDAs, INDs, Amendments, and Supplements to the FDA, ensuring full compliance with applicable regulations and guidance.

•Prepared and submitted regulatory filings for NDA, ANDA, and related amendments, ensuring compliance with federal and state pharmaceutical regulations.

•Conducted thorough risk assessments during the R&D, filing, and post-approval stages, documenting and escalating critical issues to management.

•Assists analytical and process science on authoring developmental protocols and reports.

•Co-ordination of timelines,document revisions and review cycles for all GMP documents.

•Manage validation projects within regulated environment,understanding of 21 CFR Part 11.

•FDA GXP requirements and computer system validation documentation with GDP.

•Review of completed batch records and other GxP documents in collaboration with QA as needed to ensure accuracy and completion in accordance with cGMP regulations.

•Supports preparing qualification master plans,risk and impact assessments,protocols and summary reports and co-ordinates review and approvals of the documents.

•Actively participated in the evaluation and adaptation of business processes in response to new regulations and industry guidelines.

•Supported ongoing regulatory compliance activities by reviewing documents such as batch records, test methods, and specifications.

•Authors,reviews,updates and assists in developing departmental SOPs and qualification documents/programs, also Identify and anticipate risk of non-compliance and address them.

•Analyze QMS metrics and develop recommendations for improvements to the management.

•Ensures that all activities are in compliance with cGMP,HA regulations and the client policies.

Bellerophon Therapeutics,NorthBrunswick,NJ Aug 2018 to Jan 2019

Lead Regulatory Specialist

•Member of professional team for commercial deployment of the iNO pulse delivery system of current clinical trials and responsible for Mark-2 device evaluation,calibration,compliance log,testing.

•Knowledge of lean six sigma,continuous process improvement throughout the enterprise.

•Follow international regulations like code of federal regulations(CFR), european union medical device (EU MDR), quality system regulation(QSR), quality management system for medical device (ISO 13485), medical device single audit program(MDSAP) and pharmaceuticals and medical devices agency(PMDA),international medical device regulators forum(IMDRF).

•Assessed risks throughout the R&D, filing, deficiency rounds, and post-approval phases, documenting and escalating issues to senior management when necessary.

•Possess experience working in pharma industry in a regulated IT environment with complete drug life cycle Process,ranging from drug discovery,clinical trials,manufacturing to pharma sales and marketing.

•Perform laboratory activities,deployment of high quality,reliability drug delivery system helps medical device verification to follow FDA,risk management,QMS,continuous improvement,regulatory compliance.

•Responsible for ISO 13485 for quality management system for medical device.

•Ensure consistent quality throuout a medical device lifecycle from design to disposal for patient safety.

•Involved in analysis of linear regression of the flow volume and reporting of slope and intercept an error.

Becton Dickinson,FranklinLakes,NJ March 2017 to June 2018

Regulatory Affairs Specialist

•Knowledge of design control and working with Instron tensile tester with blue hill 3.

•Reading and understanding assembly drawings,manufacturing,test instructions and service manuals.

•Involved in Regulatory Submission process to demonstrate product’s safety,efficacy and quality,

•Knowledge of all phases of SDLC/CSV lifecycle for enterprise system applications including agile validation methodologies in scrum environments and client specific methodologies,assist in product and prototype testing.

•Document test results and communicate with R&D engineers as required,strong technical writing skills for project and regulatory documentation,also participate in gauge R&R studies.

•Knowledge of EUMDR,EMA regulation to govern the production,distribution and clinical investigation of medical devices.

•Handling customer complaint reportsina timely manner and in compliance with FDA regulations, interacting with regulatory agencies, and recommending corrective actions for non-conformities.

•Collaborate with cross-functional teams, train other departments, and support the development of process and product protocols as well as other jobs assigned when needed.

•Follow guidelines of American Society for quality (ASQ) to improve the quality of medical device .

•Provides feedback to medication and procedural solutions (M&PS) research and development,advanced product Development services (APDS),knowledge on testing software,firmware and hardware by test protocols.

•Play a critical role in supporting the group’s efforts with respect to medical device testing product for design verification and shelf life,test method validation summary report.

•Supports all product development and product engineering platforms across MPS,help the team by way of expertise and efficiency in a variety of mechanical,physical and electronic testing of medical device products.

•Contribute to the improvement of existing testing methodologies,measurement system development and analysis of test methods,competitive analysis,test performed by following test protocol or test instruction.

•Responsible for the testing will help products to meet customer’s expectations and regulatory requirements.

•Product development processes,regulatory,quality requirements and design controls,such as 21 CFR 820.30.

•Responsible for ISO 13485 for quality management system for medical device.

•Ensure consistent quality throuout a medical device lifecycle from design to disposal for patient safety.

•Perform measurement system analysis for different products and testing for other medical device.

Bureau Veritas,Linden,NJ Oct 2016 to Feb 2017

Laboratory QA Inspections Supervisor

•Operates laboratory equipment and instruments such as microscopes,centrifuge,agitators,viscometer,chemical balance scales,spectrophotometer,gas chromatograph,colorimeter and other equipments.

•Maintaining a GMP and GLP environment,including equipment maintenance and calibration management.

•Test materials for presence and content of elements or substances such as hydrocarbons by ASTM methods.

•Proficiency in documenting results according to good documentation practice standards.

•Prepares graphs and charts and calibrates laboratory instruments.

ExxonMobil,Clinton,NJ May 2015 to Nov 2015

Research Engineer

•Coordinates and develops with analytical,process science, engineering and QA team qualification projects and plans identifies the “critical to quality” parameters impacting qualification activities.

•Analytical skills to determine quality and reliability improvements based on laboratory results.

•Responsible for careful,deliberate,disciplined,meticulous and well organized in performing laboratory testing and recording results,follow GHS of classification,labeling chemicals,SDS,EHS label creation,near misses.

•As per OSHA regulation updated data in share point for the new chemicals SDS,order shipment review and release,compliance with all federal,state and local regulations,implements policies and procedures,knowledge of EPA and DEA,calibration of analytical instruments.

Education:

Bachelor of Science,Chemistry : Maharaja Sayajirao University of Vadodara (India).

Skills

Regulatory Filings: ANDAs, NDAs, Amendments, Supplements, INDs

FDA & ICH Guidelines: Knowledgeable in FDA and ICH regulatory standards for pharmaceuticals

Risk Management: Ability to assess and document risks throughout the R&D and approval phases

Regulatory Compliance: In-depth knowledge of cGMP standards and federal and state pharmaceutical regulations

Communication: Strong written and verbal communication skills for FDA interactions and internal coordination

Software: Proficient in TrackWise Harmony, FDA CDER NextGen Portal, Microsoft Office Suite

Project Management: Skilled in managing multiple projects and meeting deadlines in a fast-paced environment

Contact this candidate