Regulatory and Quality Assurance Specialist

• Oct 2018 - Present

-Maintain Novo Surgical's Quality Management System i.e., regulatory documents according to FDA regulation i.e., 21 CFR 820. -Review and edit Quality Management System policies and procedures, and design history files for clarity, accuracy and compliance with ISO 13485:2016, and ISO 14971. -Act as a lead company representative in auditing activities from the different regulatory agencies (FDA, Notified Body). -Ensured facility and product registrations, product recalls and investigations were documented and maintained appropriately to help ensure a constant state of inspection readiness. -Independently map out filing and regulatory strategies for domestic and international product submittal processes. -Generate regulatory documents including Technical Files, Declarations of Conformity, Certificates to Foreign Government, and Certificates of Origin used for global product registration. -Provide regulatory support for the implementation of filing strategies for new markets in Canada and Saudi Arabia to expand the global footprint of the company. -Determine GUDID UDI labeling requirements for over 10,000 products, in addition to reviewing and approving final labeling and packaging. -Prepare investigational reports for field corrections, post-market surveillance and filed U.S. FDA MedWatch Form. -Participate in the company's internal audits and oversees yearly management review meetings. -Identifies technical components of various research and development related to new product development, pre-submission strategies, potential regulatory pathways and follow-up of submissions under review. -Work in cross-functional teams in developing relationships with suppliers and customers to effectively communicate appropriate regulatory requirements and opportunities.

Project Associate-Regulatory

• Apr 2018 - Jun 2018

• Assisted in the writing of documents for FDA Pre-Sub meetings, IDEs, INDs, Orphan Drug Applications, and 510(k) and De-Novo 510(k) applications. • Prepared SOPs and documents for Quality Assurance. • Delivered regulatory strategy for new device approval. • Worked with the Director of Clinical research to prepare clinical trial protocols and Informed Consent Forms (ICFs). • Assisted in the writing of documents for FDA Pre-Sub meetings, IDEs, INDs, Orphan Drug Applications, and 510(k) and De-Novo 510(k) applications. • Prepared SOPs and documents for Quality Assurance. • Delivered regulatory strategy for new device approval. • Worked with the Director of Clinical research to prepare clinical trial protocols and Informed Consent Forms (ICFs).

Regulatory Affairs Specialist

• Sep 2017 - Apr 2018

•Worked within the Regulatory Affairs team, focusing on the eCTD submissions software packages. •Created content templates regulatory documents of IND, NDA, BLA, 510k, PMA and EMA applications and Design History File , including the development of a walkthrough help guide and use cases. •Worked on Quality Assurance documents like SOPs, Master Records, Adverse Event Reports, Safety Reports, inspection reports, test records, and Device History Records, MDR Reports, Labeling- Package Insert and Product Label, Master Records, Batch Records, Risk management files. •Worked on on Regulatory Binder and eTMF Files- Clinical study reports, Clinical protocols, Case Report Forms, Investigator’s brochure, Financial Disclosure Form, Technical summaries of safety and effectiveness and post-approval documents. •Published a Research paper-White paper titled, “ Large Pharmaceutical Companies: the value of publications in the path to approval.”

Experiential Network Project

• May 2017 - Jun 2017

• Partnered with One million acts of Innovation for the Market Research for SaaS targeting Retail Chain Pharmacies, through Northeastern University’s Experiential Network, carrying out remote project work while completing graduate coursework in the MS in Regulatory Affairs for Drugs, Biologics and Medical Devices. • Identifying the existing North American Retail Pharmacies and the business models (subscription, capital purchase, etc.) and pricing structures of current competitive products to support the Commercialization Plan / Launch of a new business venture.

Intern

• May 2015 - Jul 2015