Medical Device Project Management
Resume:
Viral Pravin Parekh
***************@*****.***
Career Objective
To work for an organization which provides me the opportunity to improve my skills and knowledge to growth along with
the organization objective.
Profile Summary
Thorough understanding about utilization of Code of Federal Regulations like 21 CFR 50, 21 CFR 56
Working Knowledge about Electronic Common Technical Document format, GCP, GMP, ICH.
Understanding about utilization of USFDA guidance documents and EU directives while preparation of Regulatory Submissions.
Well versed with IND, NDA, BLA, PMA, IDE, 510(k) submissions.
Thorough understanding of human experimentation including informed consent forms, Investigator’s Brochure,
GLP and GCP compliance.
Well versed with medical devices regulations and development De Novo Submissions, Humanitarian Device
Exemption, Quality System Regulations 21CFR 820, CAPA, Post Marketing Activities and Post Market Surveillance Studies.
Regulatory knowledge of Drug Development Process including ANDA, Orphan Medicinal Product Designation,
CMC Guidelines, CGMP Regulations for Drug: 21CFR 210 and 211, Regulations and Policies associated
with Drug Post Marketing Activities.
Proficient with MS Word, Excel, PowerPoint and Adobe.
Personal Qualities
Highly motivated and eager to learn new things.
Strong motivational and leadership skills.
Ability to produce best result in pressure situation.
Excellent communication skills in written and verbal both.
Ability to work as individual as well as in group.
Academia
Northeastern University
Masters in Regulatory Affairs December 2017
GPA 3.8
Relevant Courses: New Drug development, Drug and Medical device development, Human Experimentation,
Advanced writing in Biomed, European, Canadian, Asian and Latin American regulations, Regulatory advertising
and promotion, Emerging trends in medical device industry.
Activities: Workshop on International Student Forum for U.S job search, Worked as Student Proctor,
Active member of University’s Student Conduct Board.
Parul Institute of Pharmacy and Research
Bachelors in Pharmacy June 2015
GPA 3.8
Professional Summary
KP Laboratories March 2015-August 2015
Assisted in maintenance of quality systems to ensure compliance with ISO and QSR.
Assisted with CAPA and inspection activities.
Assisted the Director of Regulatory Affairs with data validation process.
Revised and reviewed quality GMP documents like product dossiers, BMR, SOP and validation protocols/reports.
Assisted in supervising quality checks of regular production in a regulated plant.
Actively participated in process validation, execution of validation protocols and sampling as per protocol.
Technical Skills
MS Office
Molecular and organic Chemistry
Data analysis with MS access and excel
Certification
Project Management (Lynda.com)
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