Medical Device Project Management

KALPIT KAMLESH PATEL

** **. ********* ******, ***. 809, Boston, MA 02120 510-***-**** ***********.**@*****.*** LinkedIn: http://linkedin.com/in/kalpit-patel-13785210a Skype: ktplind ACADEMICS

Northeastern University, College of Professional Studies, Boston, MA. Jan 2017-Present Master of Science in Regulatory Affairs for Drugs, Biologics & Medical Device GPA 3.5/4 Gujarat Technological University, Sigma Institute of Pharmacy, Ahmedabad, India. Aug 2012-Jun 2016 Bachelor of Science in Pharmacy GPA 7.77/10

EXPERIENCE

Goverdhan Medico, Vadodara, India Jul-Oct 2016

Pharmacist

Interpreted prescriptions to dispense medicines with a touch of patient counselling.

Established excellent customer relationship through good interpersonal skills. Gujarat Liqui Pharmacaps Pvt. Ltd., Vadodara, India Jun-Aug 2015 Summer Internship

Got acquainted with the functioning of a Pharmaceutical industry and hands on experience on all aspects in a soft gelatin capsule making company.

Obtained sound knowledge in operations like measuring TDS for different types of water used in production, Bloom strength of gelatin, Quality control of finished product & packaging materials and Maintaining BMR’s. SKILLS

Regulatory: PREA waiver/deferral, AERS reports & Package insert analysis, Warning letter analysis, Clinical Trial forms, Clinical Study Reports, PMS.

Submissions- IND, 510(k), IDE, BLA, PMA, HDE, IVD, HUD, ANDA, NDA, eCTD.

Quality- GMP, GLP, GCP, QSR, CAPA, ISO 13485 (QMS), ISO 14971 (QRM).

Regulations- U.S. FDA, ICH, WHO.

Strategic Planning & Project Management- GHTF, IMDRF.

Computer: MS PowerPoint, Word, Excel, Outlook, Adobe Acrobat.

Communication: Spanish (Novice).

ACADEMIC PROJECTS

Due Diligence Research Project: RESURE SEALANT

Enacted as Regulatory consultant and researched through CDRH’s 510(k) clearance database to choose a product.

Prepared a presentation justifying why my device should be considered an asset for the company. Medical Device Submission Business Strategy

Prepared and presented 510(k) Medical Device Submission Business Strategy.

Accounted applicable CFRs & Guidance documents for my device. REVIEW PUBLICATIONS

1. ZIKA virus infection: threat to human life in European Journal of Pharmaceutical and Medical Research; Vol. 3, Issue 6, June 2016; Kalpit Patel, *Dr. Hitesh Jain, et. al. 2. Role of NEPRILYSIN inhibitors: combinations in cardiovascular disease in World Journal of Pharmaceutical Research; Vol. 5, Issue 5, May 2016; Kalpit Patel, *Dr. Jagdish Kakadiya, et. al. VOLUNTEER

American Red Cross, MA (once a month) Jul 2017-Present Blood Drive Donor Ambassador

Regulatory Affairs Professional Society (RAPS) Oct 2017-Present Social Media Outreach

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