H emang R. Kotecha

857-***-**** acato3@r.postjobfree.com

S UMMARY

Accomplished RA professional with around two years of experience in US, EU and International regulatory submissions

Ability to develop regulatory strategies for new technologies and products

Analytical, detail-oriented and a team player with excellent project management, communication and problem-solving skills

S KILLS & EXPERTISE

Global medical device regulations/submissions - US, Europe, Australia, Canada, Latin America, Asia-Pacific

Medical device submissions - FDA 510ks, IDEs, PMAs, PMA Supplements, EU Technical files & Design dossiers, Australia TGA

Technical files, Canadian Medical Device License Applications (CMDL)

Medical device regulations - 21 CFR, QSR, MDD 93/42/EEC, IVDD 98/79/EC, CMDR, ARGMD, ISO standards, cGMP, FMEA,

MDR, CAPA, IEC 60601 2nd & 3rd editions and electro-medical regulations, Labeling regulations, Design control requirements

Drug & biologic submissions - eCTDs, INDs, NDAs, ANDAs, BLAs, Annual Reports, CBE-30, CBE-0, PAS, CMC, MAAs

P ROFESSIONAL EXPERIENCE

Regulatory Affairs Specialist/Consultant Jun 2012 - Oct 2013

Bracco Diagnostics, Inc., Melville, NY

Assisted in preparing FDA 510k submission for obtaining marketing clearance in US

Prepared Non-filing Justifications ("letters to file") for device/label minor changes to 510k cleared products

Prepared EU Technical File for CE Marking of a Class II device

Updated EU Technical files for device/label changes, standards updates and address change to comply with MDD 93/42/EEC

Drafted ERC & Declaration of Conformities based on MDD, and Essential Principles Checklist based on ARGMD

Submitted Medical Device License Renewal and License Amendment Applications to Health Canada

Assembled documents for product registration renewals/amendments in Guatemala, South Korea, Mexico, Brazil

Prepared ISO 14971 Internal Audit checklist for gap analysis in the risk management process

Collaborated with SMEs and cross-functional teams regarding material information of products

Created Document Change Orders (DCOs) for change implementation

Tracked product registration status, renewal requirements, file renewals as well as standards for regulatory compliance

Advised product development teams on pre- & post- market regulatory requirements

Regulatory Affairs Intern Jul 2011 - Dec 2011

ConforMIS, Inc., Burlington, MA

Assisted in preparing FDA Special 510ks and EU Technical Files & Design Dossier for orthopedic knee replacement devices

Prepared Clinical Evaluation Report (CER) for a Class II device

Revised & drafted SOPs and Work Instructions for (1) Recall process, and for preparing (2) Declaration of conformity

Created Regulatory Strategy/Impact Form to evaluate proposed device changes and for 510k/No-510k submission decision making

Submitted Request for Eligibility for Small Business Qualification under MDUFMA to the FDA

Created Engineering Change Orders (ECOs)

E DUCATION

Northeastern University, College of Professional Studies, Boston, MA Apr 2012

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices

University of Mumbai, Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, India Jul 2010

Bachelor of Pharmacy

A CADEMIC PROJECTS

Developed a Regulatory Strategy and a Submission Plan for a hypothetical Combination Product

Prepared a Pre-IDE Meeting Request to FDA

Performed FMEA of a hypothetical ablation catheter and calculated the overall risk (Pre - & Post- mitigation risks)

Drafted IND/NDA for a hypothetical drug, and BLA for a hypothetical biosimilar (follow-on biologic)

Audited and performed simulated manufacture of drug product as per cGMP regulations; also submitted an audit report

Submitted a white paper on 'Managing a Medical Device Recall: From First Alert to Effectiveness Checks'

C OMPUTER SKILLS

Regulatory softwares - Agile, Trackwise, Documentum based software xPression (Expresso)

MS Office Applications (Word, Excel, PowerPoint, Outlook, Project, SharePoint etc.), Adobe Acrobat, Mac OS

- Available to relocate nationwide -

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