EMMANUELLA OKOLIE
Ontario,Canada
Summary
A pharmaceutical professional with six years of experience and expertise in Medical Device Regulatory Affairs. Possessing excellent project and time management skills with an understanding of and ability to navigate Health Canada's Food and Drug Acts and Medical Device Regulations to meet submission deadlines. Adept in preparing regulatory submissions, developing strategies for EU, FDA, and Health Canada's new medical device submissions, and maintaining quality management system documentation that is compliant with ISO 13485 to facilitate approval and ensure compliance.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Regulatory Affairs/Quality Assurance Associate
Canadian Hospital Specialties, CHS
08.2023 - Current
- Participated in a type 1 recall, mandatory problem reporting, documented risk evaluation, and maintained regulatory documentation consistent with regulatory format.
- Managed post-market surveillance activities, including adverse event reporting and complaint handling of both company and third-party devices, resulting in improved product safety and compliance.
- Reviewed label and promotional materials and maintained regulatory documentation, ensuring accuracy and completeness for customer audits and inspections.
- Revised and updated Standard Operating Procedures on Foreign Risk Notification to ensure compliance on incident reporting and consistency in the organization's best practices.
- Prepared and complied with changes in FDA and EU MDR for a new product registration and kept up-to date with CE markings and MDSAP EU timelines.
- Responded to inquiries and requests for proposed products and manufacturing processes and changes, and implemented the necessary changes to ensure stakeholder satisfaction.
- Prepared documentation packages relevant to MDL, MDEL renewals, and NHP site licence applications and monitored submission and approval status.
Client Experience Associate
TD Canada Trust
06.2022 - 07.2023
- Boosted customer experiences by 6% by delivering legendary customer service, timely issue resolution, and keeping a detailed daily progress record.
- Monitor completed assessments (policy development, risk assessment), perform proper analysis, and maximize customer satisfaction significantly within the department.
- Managed customer relations and customer service through daily communication and interaction by collecting and entering information into the digital database.
- Educated new hires on company policies and department procedures.
Research Assistant
University Of Ottawa
07.2022 - 02.2023
- Coordinated the planning and implementation of research projects, including designing experimental protocols and developing research materials relevant to the African, Black, and Caribbean ACB communities
- Demonstrated strong writing and presentation skills, using literature reviews to generate original reports and ensure data accuracy and project integrity.
- Performed quantitative analysis and participated in focus groups with stakeholders to collect data that informed policies relevant to COVID-19 uptake.
- Organized participant-informed consent waivers and research scope documentation to evaluate potential participants for suitability for the study.
- Coordinated community engagement with Ottawa Public Health OPH to strengthen and increase vaccine uptake in ACB communities and documented findings.
Administrative Assistant
Sterling Sun Inc
05.2021 - 10.2021
- Prepared, collected, and delivered policy documents through research and analysis to provide accurate recommendations to the management and relevant stakeholders
- Completed all tasks thoroughly, worked independently to meet deadlines and adopted a customer-centered approach
- Executed all administrative tasks necessary to support the objectives of the company.
Pharmacy Operations Manager
Britewell Pharmacy
07.2017 - 01.2021
- Conducted routine inspections to identify areas for improvement and eliminate hazards to employees and customers to ensure continued compliance with relevant regulations.
- Established procedures necessary for compounding, mixing, packaging, and labeling of OTC to help mitigate symptoms and maintained patients confidential information.
- Supervised and trained a team of four pharmacy technicians and assistants, developed procedures, and provided ongoing education for effective pharmacy operations.
- Increased patient satisfaction scores by 8% by educating patients on possible drug interactions and potential side effects through medical outreach and community engagement.
- Ordered all pharmacy supplies, kept a check on inventory levels, and customized a care plan with the patients' circle of care to improve quality of life.
Education
Postgraduate Certificate - Regulatory Affairs
Humber College
Toronto, ON09.2023
Bachelor of Science - Pharmacy
Adamson University
Manila, Philippines03.2014
Skills
- Quality Assurance
- Audit
- Regulatory Documentation
- Critical Thinking
- Pre-Market Submissions
- Data Collation
- Technical Documentation
- Change Management
- Submission Preparation
- Regulatory Compliance
- ISO Standards
- Microsoft Dynamics
- Project Management
- Complex Problem-Solving
Certification
- Medical Device Establishment Licensing and Post-Market Regulation , Health Canada and the Public Health agency of Canada - September 2023
- Good Manufacturing Practices Training for Natural Health Products , Dicentra - August 2023
- Understanding How Medical Devices are Regulated in Canada , Health Canada - Feburary 2023
Timeline
Regulatory Affairs/Quality Assurance Associate
Canadian Hospital Specialties, CHS
08.2023 - Current
Research Assistant
University Of Ottawa
07.2022 - 02.2023
Client Experience Associate
TD Canada Trust
06.2022 - 07.2023
Administrative Assistant
Sterling Sun Inc
05.2021 - 10.2021
Pharmacy Operations Manager
Britewell Pharmacy
07.2017 - 01.2021
Postgraduate Certificate - Regulatory Affairs
Humber College
Bachelor of Science - Pharmacy
Adamson University
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