Shanelle Olah

- Lead, organize and facilitate external audits for regulatory bodies. - Train and onboard new employees on the quality management systems (QMS) and WHMIS. - Liaise with external legal counsel to manage patent-related inquiries and communicate within the organization to ensure timely payment processing. - Take part in weekly upper management meetings. - Coordinate and communicate with CROs to support project timelines, provide required documentation and address inquiries to ensure alignment with study requirements and organizational objectives. - Communicate with Authorized Representatives to support medical device submissions and ensure documents are in compliance with applicable requirements for Health Canada and the European Union (EU). - Delegate tasks to other members in the department in order to ensure equal workloads.

In addition to the previously listed tasks in the Regulatory Affairs Assistant role, I: - Participated in external audits for multiple regulatory bodies such as ISO 13485 and ISO 9001. - Participated in supplier qualification audits in accordance with various requirements. - Carried out planned and unplanned deviations which included performing an investigation, assessing the risk, and determining a root cause. - Accepted returned product from customers and completed product nonconformity reports. - Registered medical devices (IVDR) into the EUDAMED database to ensure the company’s products are compliant in the EU. - Created labels for products and performed quality inspection checks. - Performed final inspection checks to ensure products contain all items listed on the batch record. - Member of Joint Health and Safety Committee (JHSC). Chair JHSC meetings, perform monthly workplace safety inspection and monthly fire drills. - Reviewed legal documents such as Master Service Agreements, Mutual Non-Disclosure Agreements, Supplier Agreements, Quality Agreements, etc.

- Perform internal audits to maintain and improve the quality management system in accordance with ISO 13485:2016, ISO 9001:2015, ISO 15189:2022, and CMDR SOR/98-282. - Assist in regulatory audits, such as ISO 13485, ISO 9001, ISO 15189, and Health Canada. - Create QOPs and SOPs and perform change requests as required. - Compile data to write and submit medical device submissions to respective regulatory bodies, such as CMDR and the European Union (EU). - Initiate Corrective Action and Preventive Actions (CAPAs), which includes an investigation, a root cause determination and assessment of the risk involved. - Perform failure mode and effect analysis (FMEA) for the workflow of a process; more specifically, the manufacturing process of a medical device. - Write validation reports to ensure a process or equipment functions as intended. - Act as a project coordinator for various original equipment manufacturing (OEM) projects. - Perform extensive root cause analyses and risk assessments of customer complaints. - Perform post-market surveillance activities for all applicable medical device families.

- Gathered and entered patient information and doctors’ prescriptions in computer systems. - Assessed prescriptions for completeness. - Prepared and packaged prescription medications. - Placed and received orders for stock to maintain inventory. - Learned and understood the billing process for various insurance companies.

- Assist with daily pharmacy activities. - Answer the phones and communicate with clients. - Dispense, label, and package medication. - Check for expired medications, check inventory, and restock drugs. - Communicate with patients and doctors. - Worked with various insurance companies to ensure medication is properly billed. - Entered Innovicare cards for various medications. - Learned and understood the billing process for various insurance companies.

- Digitized paper documents and collated them into an Excel database - Created Excel database of all jobs sold at Whiting since its inception in 1918 - Translated the English language version of the Whiting website into French - Reorganized PDF versions of Bills of Materials into a user-friendly format

- Digitized paper documents and collated them into an Excel database - Created Excel database of all jobs sold at Whiting since its inception in 1918 - Reorganized PDF versions of Bills of Materials into a user-friendly format