TABBY SHAIKH
Toronto,ON
Summary
Dedicated and detail-oriented professional with an MSc in Medical Device Regulatory Affairs, eager to apply a strong foundation in regulatory compliance to the healthcare sector. Committed to utilizing both academic knowledge and hands-on experience to streamline regulatory processes and ensure the highest patient safety standards.
Overview
7
7
years of professional experience
Work History
Regulatory Affairs Intern
Purcell Global
04.2024 - 06.2024
- Classified devices by Health Canada's medical devices classification rules and designed pre-clinical and clinical trial frameworks that align with Canadian regulations, incorporating innovative methodologies for efficiently evaluating respiratory disease management technologies
- Produced comprehensive plans for pre-clinical and clinical trial phases, including timelines, milestones, and critical considerations for success in the Canadian market
- Developed patient recruitment and data management strategies to ensure compliance with Canada's privacy laws and ethical standards
- Effectively managed comprehensive document management processes, ensuring regulatory compliance and document accuracy
- Facilitated communication between the company and Health Canada.
Executive
IFEDORA SERVICES PRIVATE LIMITED
09.2019 - 08.2022
- Submitted and processed Inpatient, outpatient, and procedure insurance claims after verification according to the criteria of different insurance within the TFL
- Reviewed patient accounts and collaborated with the medical providers to ensure billing and document policies
- Coordinated with heads of different departments for various billing issues
- Have done qualitative and quantitative audits
- Worked with different medical software.
Service Engineering Intern
AUSSIN INTENSIVE CARE PVT. LTD
06.2017 - 09.2017
- Helped regularly calibrate medical devices to ensure they provide accurate readings and outputs
- Conducted routine checks and scheduled maintenance on medical equipment
- Assisted in the installation and setup of new medical equipment, ensuring it was correctly configured and operational
- Conducted tests to verify that newly installed or repaired equipment meets manufacturer specifications and regulatory standards
- Helped maintain accurate records of maintenance activities, repairs, and service calls, including completing service reports and updating equipment logs.
Education
Master of Science - REGULATORY AFFAIRS
Northeastern University
Toronto, ON06.2024
BACHELOR OF ENGINEERING -
Gujarat Technological University
India05.2018
DIPLOMA OF ENGINEERING - BIO-MEDICAL
Gujarat Technological University
India06.2015
Skills
- Knowledge of ISO 13485:2016 Quality Management System (QMS) implementation and maintenance
- Expertise in regulatory compliance for the US FDA, Health Canada, EU MDR, and MDD
- Skilled in quality assurance processes, including CAPA, non-conformance management, and document control
- Familiar with Quality Management Standards, such as ISO 14971:2012 and 21 CFR 820
- Familiarity with both internal and external audits
- Knowledgeable in regulatory registrations for both products and sites
- Competent in conducting material inspections for both incoming and outgoing products
- Robust ability to analyze data and generate detailed reports
- Exceptional analytical and problem-solving abilities
- Highly detail-oriented with a strong focus on accuracy
- Effective in team collaboration and facilitation
- Excellent time management and organizational skills
- Strong communication abilities, including written, verbal, and presentation skills
- Adept at thriving in fast-paced, customer-centric environments
Projects
Developed comprehensive applications for Medical Device Establishment Licenses (MDEL) and Medical Device Licenses (MDL) for Class III and IV devices, including all requisite supporting documentation. Formulated regulatory strategies for Class II and III devices, encompassing 510(k) and PMA submissions with detailed safety and effectiveness data. Prepared and submitted an electronic Common Technical Document (eCTD) for a pharmaceutical product, ensuring strict adherence to regulatory guidelines. Developed a comprehensive Quality Management System (QMS) manual adhering to the regulations of 21 CFR Part 820, ISO 13485, and ISO 14971 for Class I and II devices
Additional Information
ISO 13485:2016 Medical Device Lead Auditor
Timeline
Regulatory Affairs Intern
Purcell Global
04.2024 - 06.2024
Executive
IFEDORA SERVICES PRIVATE LIMITED
09.2019 - 08.2022
Service Engineering Intern
AUSSIN INTENSIVE CARE PVT. LTD
06.2017 - 09.2017
Master of Science - REGULATORY AFFAIRS
Northeastern University
BACHELOR OF ENGINEERING -
Gujarat Technological University
DIPLOMA OF ENGINEERING - BIO-MEDICAL
Gujarat Technological University
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