Archan Dave

archan448@gmail.com contact no: 4693201590

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PROFESSIONAL SUMMARY:
 7+ years of diverse experience in Regulatory Affairs with strong hold on Medical Standards.
 Expertise on FDA's Quality Systems Regulations, US, Canadian, EU (CE Marking), Medical Electrical Safety Standards IEC 60601-1,
60601-1-2, 62366 and other Globally Harmonized Standards.
 Expert in regulatory submission for global regulatory affair (US FDA, EU (CE Marking), NMPA China, Dubai DHA, Canada eCTD,
Japan, UK NHS, South Korea, Brazil INMETRO).
 Supervision and leadership on all CMC Document preparations and confidential submissions, Batch Records,SOPs,changes
control, Nin-conformities and out of specification(oos)reporting.
 Maintained current knowledge to ensure compliance to the applicable regulatory and corporate standards/ requirements (FDA
Quality System Regulations, European Quality Standards, ISO 9001/13485, MDD, CMDCAS/CMDR, etc.
 Proven experience in gathering requirements for Labeling, UDI, Advertising and Promotion as per US FDA and EUMDR.
 Proficient with Global regulatory compliance requirements including EU MDD, EU MDR, Canada, China, and RoW.
 Profound knowledge on medical device and pharmaceutical Quality System Regulations such as 21 CFR Part 820, 803, 210, 211,
312, 314, 600, 601 ISO 13485, cGxP (GMP, GCP, GDP and GLP).
 Hands on experience in authoring technical documents (Module 2 and Module 3) required for regulatory submission.
 Experience in working with team for product registration that compliance globally such as APAC, LATAM, EMEA, CFDA, TFDA,
PMDA, MOHW, SFDA, Anvisa ANMAT, NMPA, TFDA, MFDS, MOH.
 Expertise with Microsoft Office Suite, Electronic Document Management Systems, Change Control database and Publishing
Software’s.
 Assist With specific CMC project Active including preparation of supplements and annual Reports for parenteral drugs
 Extensive knowledge of on –sites manufacturing processes and procedures.proficient in reviewing deviations,CMC changes
controls,work orders,protocols,reports,batch records,and other GMP documents
 Expertise with Microsoft Office Suite, Electronic Document Management Systems (Documentum and SharePoint)
 Good experience in writing Risk Assessment, Remediation Plan, Deviation report, and User Acceptance Testing (UAT).
 Well versed with navigating the FDA website to conduct thorough searches for guidance documents, drug approvals, labeling
information, OTC monograph list, safety information.

EXPERIENCE:
Genpact, CA February 2021 – Present
Regulatory Affairs Consultant
 Performing Analysis for the Manufacturing changes or device changes and identifying the types of registration required for it.
 Performed Full Registration, Administrative Registration, Registration Modification, Notification activities
 Identifying and collecting the documents required for registration.
 Supporting RRA’s regarding registration of the product.
 Ensuring that all the documents such as Doc (Declaration of Conformity), CE, ISO 13485, Product labels are submitted to Notified
bodies for the registration.
 Preparing and updating CMC documents for FDA and EMEA submission and rest of world submission.
 Worked on multiple countries for different products registration.
 Responsible for interacting with Clients and RRA’s.
 Reviewing, tracking, and closing of deviation’s and CMC change controls.
 Ensuring and coordinating that the CMC documentation of the product comply with the regulations of the medicines and
healthcare products and Regulatory agencies of different countries
 Regulatory interact with SMEs from CMC Regulatory submissions, Global manufacturing and supply teams for application
enhancements, functionalities review etc.
 Involved in the preparation of regulatory submissions ANDA's, DMF's, PMA, 510k's, NDA's.
 Providing the technical report on the registration activities.
 Conducted assessments to meet ISO 9001, ISO 13485, ISO 14971, and FDA 21CFR 820 requirements and ISO regulations
 Created regulatory dossiers, technical files and design dossier generated STED to support business
 Maintained current knowledge and understanding of ICH, GMP guidelines, emerging regulations, standards, or guidance
documents.
 Performing of migrating medical device registration from MDD to MDR

Zimmer Biomet, Warsaw, IN Mar 2020 – February 2021

Sr. Regulatory Affairs Consultant
 Responsible for regulatory functions including planning, strategic path and filing of documentation with domestic and
international agencies, compliance with regulations.
 Charged with Regulatory Affairs support in the remediation projects for Class II and Class III devices in US, China, and EU market.
 Reviewing and Analyzing CMC data for compliance with requirements for Biologics License Application as per guidelines
published by FDA and other international agencies.
 Communicated with multiple departments (QA, QC, Manufacturing, R&D, etc.) to obtain technical and clinical documentations
and analyze for compliance with current regulations.
 Worked on the Regulatory Criteria through the Special Protocol Assessment (SPA), Quality System Regulations (QSR), cGMP, and
ISO 13485.
 Preparing CMC documentation for new product licenses and License Renewals.
 Prepared and proofread of FDA special 510k for class II, III products.
 Responsible for interacting with international regulatory agencies (MHRA, PMDA, TGA, etc.) and FDA.
 Involved in the preparation of regulatory submissions ANDA's, DMF's, PMA, 510k's, NDA's.
 Provided technical review of data, change control data base or reports that will be incorporated into regulatory submissions to
assure scientific rigor, accuracy, and clarity of presentation.
 Ensured regulatory compliance with IEC 60601-1 and appreciate collateral and standards.
 Involved in preparation of regulatory documentation including CMC sections, Clinical Trials, Literature searches to support
submission, FDA product analysis, protocol development, Development, publishing to FDA, and other Regulatory.
 Conducted assessments to meet ISO 9001, ISO 13485, ISO 14971, and FDA 21CFR 820 requirements and ISO regulations
 Created regulatory dossiers, technical files and design dossier generated STED to support business
 Maintained current knowledge and understanding of ICH, GMP guidelines, emerging regulations, standards, or guidance
documents.
 Developed and designed products specification and CMC documents for IND/NDA/Sand using CTD format.
 Interacted with technical groups and understand complex issues pertaining to CMC, packaging, and testing.
 Conducted QMS remediations including ISO13485:2016, UDI, MDSAP, LATAM, APAC, and EU MDR.

Cook Medical, Bloomington, IN Dec 2018 – Feb 2020

Regulatory Affairs Consultant
 Involved in GAP analysis for User requirements and developed Remediation plan to ensure compliance with FDA regulations.
 R&D lead for all design control areas to confirm product performance, including design verification & validation planning and
execution in compliance with ISO standards and the US/ EU regulatory requirements.
 Responsible for Quality Management System (QMS), per ISO 13485, and implementing Master Control document management
system.
 Authored 510k, EU dossier, PMA, and submission (US, EU, and China)
 Responsible for completing any required testing or labeling revisions to comply with EU MDR regulations.
 Prepared Harmonized standards for the Technical Files and update in compliance to MDR.
 Performed GAP analysis on technical files and applicable standards for Vital signs, Thermometry, physical examination, and
endoscopic product families.
 Ensured regulatory compliance with IEC 62305 and IEC 62366.
 Primary liaison between extended overseas team and client leading review activities of MDR GAP assessments.
 Performed ISO 13485 Quality System review and ISO 14971 Risk Management audit review of medical devices, IAW 21 CFR 820.
 Conduct QMS remediations including ISO13485:2016, UDI, MDSAP, LATAM, APAC, and EU MDR.
 Supported Marketing, R&D and Manufacturing teams with regulatory assessments of proposed changes or product transfers
 Designed test fixtures for reliability testing of components while following developed FMEAs or Fault Tree Analysis tools to
diagnose design or manufacturer defects
 Responsible for updating design and requirements of technical files STED, DHF, DID, GSPR as per EUMDR regulations.
 Redlined device, accessory, packaging and shipping labels and updating the labelling / packaging specification.
 Revised DFU’s and preparing DVVP’s to mitigate the gaps identified across DHF and other QMS documentation.
 Delegated in Risk management remediation, mapping the risks traceability to several design requirements across DID, SRS and
other parts of DHF.
Varian Medical, Mumbai, India Mar 2016 – Jul 2018
Regulatory AffairsEngineer
 Assisted Manager/Organizing 510k submissions and technical files, writing FOI (Freedom of Information) requests to FDA for
product information as needed. Collaborated with cross-functional global teams to determine regulatory pathway for Class I/II
Disposable, Sterile product lines.
 Involved in GAP analysis for User requirements and developed Remediation plan to ensure compliance with FDA regulations.
 Compilation, development, and maintenance of EU and US Regulatory submissions & coordinating with the respective
functional group.
 Created plans, protocols, and procedures to bring products in compliance with the EU MDR
 Development of regulatory submission for implantable medical devices. Prepared Technical files documentation. Reviewed the
FDA regulatory submission process.
 Assisted with regulatory activities for recalls and post market activities. Maintained various regulatory trackers and matrixes for
Corporate and Regulatory Compliance
 Improved CAPA system performance and metrics by reducing open CAPA’s on material and inspection gauges.
 Prepared, and submitted US Regulatory files (510(k)s, PMAs) and/or European technical files and design dossiers.
 Performed verification activities and demonstrated alignment with Site Quality Management System and corporate standards /
applicable global documents by verification gap analysis.
 Cross functional team member for both Design and Quality teams involved in writing design specifications for Class II and Class
III medical devices.
 Formulated Master Validation Plan (MVP) and Master Validation Report (MVR) for new and existing sterile manufacturing
equipment, processes, and material.
 Assisted in GMP operations by checking calibration log sheet, portable or fixed vessels/tank operation log sheet and equipment
usage status.

EDUCATION: Master of Science (MS), Mechanical Engineering, California Baptist University, CA