Medical Device Product Development

Gayatree Yadav

+1-203-***-**** *************@*****.***

Authorized to work for any employer in US

SUMMARY

Sturdily consistent and focused Regulatory Affairs professional intending to build an extensive career in Regulatory Affairs with an eminent academic background and great depth of experience in the healthcare/pharmacy industry.

Thorough academic exposure to US FDA, EU, Health Canada regulations, GCP, CGMP, Quality Standards

An understanding of Informed Consent, IRB review, ethical principles in clinical research and experienced in DEA and HIPAA compliance

An understanding of MedDRA coding system, triaging, assessing and performing data entry of adverse event information

Working experience in the pharmaceutical industry in India and hospital Pharmacy/retail pharmacy in USA

Strategic thinker with strong attention to detail and with excellent communication skills.

Proficient in MS Word, Excel, PowerPoint and familiarity with SPSS

Knowledge of AMA style, medical terminology, current medications in the market, product recalls and clinical data analysis

Familiarity with the general requirements for medical device regulation in Canada and in Australia

Highly skilled in sourcing Conferences, Journals, News Releases related to the therapeutic Drugs, Biologics, and Medical Devices

Efficient in handling the client queries

EDUCATION

Candidate for M.S. in Regulatory Affairs for Drugs, Medical Devices and Biologics

Northeastern University, Boston, MA

2015- 2017

Bachelor of Pharmacy

North Gujarat University, Gujarat, India

Relevant Coursework: Drug and Medical Device Law, Drug and Medical Device Regulations, New Drug Development: Regulatory Overview, Biologics Development: Regulatory Overview, Medical Device Development: Regulatory Overview, Human Experimentation: Methodological Issues Fundamentals, Clinical Trial Design Optimization and Problem Solving, Canadian and Australian Medical Device Regulations

EXPERIENCE

Start-up at Harvard Innovation Lab Boston, MA

Regulatory Affairs Intern Sept 2016-June 2017

Developing the regulatory strategies for de novo medical device, product development description and preparing the product labeling for the medical device for clinical studies

Assisting in development of SOPs and the revisions

Reviewing medical device regulatory standards and updating to ensure the compliance.

Updating procedures following ECO or engineer’s instructions.

Maintaining collaborative relationships with external partners including regulators and suppliers

CVS Pharmacy (MGH Main Campus) Boston, MA

Registered Pharmacy Technician Sept 2015- March 2017

Collected, organized and evaluated patient information, managed medication distribution, and provided information and education to the customers.

Prepared, labeled, dispensed and distributed medications under direct supervision of the pharmacist

Maintained ethical conduct by protecting the confidentiality of patient information

Performed inventory of medications daily or as needed

Checked and maintained regulatory documents as per the standards of DEA.

Coordinated and communicated with patients, providers and third party (insurance, vendors) to resolve issues and query.

ACADEMIC REGULATORY PROJECTS COMPLETED

Created an Investigational product labeling for an FDA-approved drug following the guidance document “Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements”.

Developed an Investigator’s Brochure (IB) for a FDA-approved drug and obtained an understanding of the importance of this document in a clinical trial setting.

Prepared MAUDE adverse event report for a PMA approved device and gained a thorough understanding of regulatory concepts such as device class, event summary, event type and Manufacturer narrative.

Analyzed the HDE Approved device and gained a thorough understanding of regulatory concepts such as HDE number, product code, advisory committee and panel meeting.

Created a mock SOP, gained an understanding of various parts and procedure of writing a comprehensive SOP.

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