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Medical Device Manager

Location:
Boston, Massachusetts, United States
Posted:
May 16, 2018

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RIKIN GANDHI

***, **** *****, ********* # **, Boston, MA 02215 617.***.**** ac5hco@r.postjobfree.com

https://www.linkedin.com/in/rikin-gandhi

EDUCATION

Northeastern University, Boston, MA GPA 3.96 Expected July 2018

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

Related coursework: New Drug Development: A regulatory Overview, Medical Device Development: A Regulatory Overview, A Biologics Development: A Regulatory Overview, Introduction to Drug and Medical Device Regulations, Strategic Planning and Project Management for Regulatory Affairs, Regulatory Writing, Global Biotech Development,

NMIMS University, Mumbai, India GPA 3.49 August 2009-July 2011

Bachelor of Pharmacy

Related coursework: Pharmaceutical technology, Pharmacology, Pharmaceutical Biotechnology, Drug Design, Good Manufacturing Practices (GMP), Quality Assurance, Drug Regulatory Affairs, Medicinal Chemistry, Novel Drug Delivery System, Pharma Industrial Management,

Maharashtra State Board of Technical Education, Mumbai, India, Percentage: 76.10 August 2007- July 2009

Diploma in Pharmacy

Related Coursework: Pharmaceutics, Pharmacology, Hospital & Clinical Pharmacy, Pharmacology & Toxicology, Drug Store & Business Management, Health Education & Community Pharmacy

SKILLS

Effective Communicator, Analytical & Problem-Solving Skills, Computer Proficiency & IT Skills, Team Leading & Group Working Ability, Professional Approach, Keen Observer & Attentive Listener, Strong work ethics

US Regulatory: US-FDA 21CFR regulations, ICH guidelines, CTD format, IND, NDA, Process Validation, QSR, PMA, PMS, Medical Device Development, GMP, GLP, GCP, 510(k) submissions, PDUFA, ISO standards, Labelling familiarity with FDA regulations and statutes, eCTD.

EU Regulatory: Biotechnology regulation, EU MDR, EU directives, Post-market vigilance of medical devices,

Other Global Regulatory: Overview of the regulatory bodies and regulations in Latin America, China, India, Singapore, Australia, South Korea, Malaysia and Canada – CTD, Harmonization Task Force, multinationals documents from APEC, ASEAN, MERCOAUR, Pan American, WHO and STED.

Registered Pharmacist-India

WORK EXPERIENCE

Experiential Learning Intern– LiLu, Inc April 2018- Current

Identified & prioritized potential market for commercialization of maternal health device through market analysis, and regulatory hurdles.

Interpreted major regulatory hurdles and advised sponsor on regulations applicable to maternal health device.

Strategized regulatory requirements including determination of medical device classification, establishment & registration requirements (essential principles, conformity assessment etc., DEAL submission, GMDN code and terms) for Australia, India, and New Zealand.

Provided regulatory strategy for proposed maternal health device for obtaining approval in a timely manner in Australia, India, and New Zealand.

Medtronic & Cardinal Health, Mansfield, MA July 2017- April 2018

Post-Market Surveillance Specialist

Evaluation of incoming complaint information and maintains it in the electronic database.

Determining reportability (MDR/AE) of complaints to FDA and other international regulatory agencies including EMA, TGA, HAS, ANVISA.

Closely monitor quality, completeness, and timeliness of complaint investigations and files following Good Documentation Practices.

Review, analysis on complaint data and escalate issue and trends to management and other departments as needed.

Working with cross-functional teams to ensure proper communication and evaluation/investigation of customer issues.

Working Experience of more than 9 months with SAP’s Global Complaint Handling System.

Savli Bio-Incubator, Gujarat State Biotechnology Mission- Gandhinagar, India April 2015 - August 2016

Incubation Associate cum Manager

Took the responsibility of an Incubation Associate cum manager position to lead a technology business incubator while continuing my research activity in nutraceuticals.

Played instrumental role in commercialization of the product from the stage of ideation.

Served as a central contact point for all incubates and/or all matters related to incubation inclusive of Coordination, Communication, Documentation, Planning, Organizing, Studying.

Served as a member of Gujarat State Biotechnology Project Evaluation Committee to assess the funding requirements, social, and commercial potential of the research.

Played a crucial role in conceptualization, designing and implementation of two ambitious program of Dept. of Biotechnology, Government of Gujarat – The Idea Doodle Lab, and the IP Clinic.

New Royal Chemist- Mumbai, India July 2011- Feb 2015

Pharmacist & Management Executive

Served as Senior Pharmacist and Management Executive to oversee operations of organization.

Undertook the horizontal and vertical expansion of the business and established two more business set up as a part of the horizontal expansion of the business actively working with the Food & Drug Administration, Mumbai, India for licensing requirements.

INTERNSHIP

Zydus Cadila, Technology Center, Ahmedabad, India Feb 2010- May 2010

Developed Transdermal Drug Delivery System using novel polymer for pain management

Witnessed operation of solid dosage form, sterile dosage form and Inhalation therapy inclusive of working of sophisticated machine operation.

ACADEMIC PROJECT WORK

“Discovery of Drug Targets and Investigation of New Antiviral –Anti-Rabies Agents” March 2011-May 2011

The objective of the project work was the identification of targets and potential molecules as an oral anti-rabies agent.

Identified more than ten herbal molecules that can act against spread of the rabies virus in body and explored their potential as a prophylactic agent.

References available upon request



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