In my current role within the Supply Chain Team, I contribute to Supplier Quality Development at Clarius Mobile Health. Collaborating closely with suppliers, working on quality assessments of incoming materials. My responsibilities extend to seamless collaboration with the Quality Control, Production, Hardware Engineering, and Manufacturing Engineering teams to uphold the highest standards in material quality.

As the Quality Assurance/Regulatory Affairs Manager at Clarius Mobile Health, I played a pivotal role in ensuring the highest standards of product quality and regulatory compliance. My responsibilities included:• Regulatory Compliance Leadership: Led compliance efforts with FDA, EU Commission, Health Canada, and ISO 13485 standards, ensuring seamless adherence to global regulatory requirements.• Submission Management: Orchestrated successful submissions to regulatory bodies, facilitating product approvals and compliance with stringent regulatory frameworks.• Audit Preparedness: Spearheaded internal and third-party audits, maintaining a state of audit readiness and consistently achieving positive outcomes.• Quality Management System (QMS) Maintenance: Implemented and maintained robust Quality Management Systems, serving as the backbone for continuous improvement and adherence to quality standards.• Global Regulatory Submissions: Collaborated with the sales department on Rest of World submissions to regulatory bodies, ensuring comprehensive market access and compliance.• Cross-Functional Collaboration: Worked closely with Research and Development teams on new projects, embedding quality into the product development lifecycle.This multifaceted role equipped me with comprehensive expertise in quality assurance and regulatory affairs, contributing to the overall success and growth of Clarius Mobile Health.

In my role as Office Manager & Quality Specialist at ARTMS Products Inc., I undertook a diverse set of responsibilities during the company's startup phase. While officially titled as Office Manager, my role extended beyond traditional office management and embraced operational aspects.Key Contributions:• Operational Integration: Led the creation of the first office, orchestrated the move to a second office, and played a key role in setting up a fully functional laboratory, showcasing adaptability.• Managed Purchasing: Oversaw procurement processes, ensuring cost-effective and timely acquisition of necessary resources.• Quality System Implementation: Pioneered a comprehensive quality system, enhancing regulatory compliance and operational excellence.• Finance Coordination: Collaborated with the accountant, ensuring financial accuracy by aligning purchases with accounting records.• Executive Support: Provided crucial support as a reliable Personal Assistant to the CEO, CFO, and CTO.• Logistics and Shipping Management: Organized product shipping, streamlining logistics for efficiency and ensuring timely deliveries.• Event Coordination: Managed events, including trade shows, customer meetings, and audits, contributing to industry presence.• Marketing Initiatives: Played a pivotal role in marketing, contributing to the website, promotional videos, and design of marketing materials.• Human Resources: Active role in recruitment, conducting interviews, and contributing to onboarding.• IT Setup: Assisted in setting up IT services, ensuring a smooth and effective IT infrastructure.This startup experience allowed me to significantly contribute to ARTMS Products Inc.'s efficiency and success, showcasing adaptability and commitment to operational excellence.

As a Quality Assurance Associate at Layfield Group Limited, I played a vital role in ensuring the highest standards of product quality and safety. Key responsibilities included:• Quality Control Testing: Conducted meticulous quality control testing procedures to maintain the integrity of the products, ensuring they met specified standards.• Incoming Material Checks: Batch checked incoming supplier materials to ensure they met quality control specifications before being introduced into the production process.• Daily Inspections and Safety Audits: Performed daily inspections and safety audits of the production area, identifying potential hazards and ensuring a secure working environment.• Document Control: Managed critical documents related to quality assurance, contributing to the organization and efficiency of quality workflows.This experience at Layfield Group Limited deepened my understanding of quality assurance processes and honed my ability to uphold rigorous standards within the Quality Department of a dynamic manufacturing setting.

As a Regulatory Affairs Officer and Quality Assurance Associate at Viva Pharmaceutical Inc., I played a pivotal role in ensuring adherence to industry regulations and maintaining high-quality standards. Key contributions include:• Internal Auditing: Conducted comprehensive internal audits to assess and improve compliance with regulatory requirements, fostering a culture of continuous improvement.• Regulatory Compliance: Ensured that finished goods met stringent Health Canada and FDA regulations, meticulously verifying adherence to quality standards.• Good Manufacturing Practices (GMP): Implemented and monitored GMP protocols to guarantee the highest standards in manufacturing processes, contributing to the overall quality and safety of products.• Product Label Review: Thoroughly reviewed and validated product labels to ensure accuracy, compliance, and alignment with regulatory guidelines.• Document Control: Managed and controlled essential documents within an existing organized system, ensuring smooth workflows and efficient compliance with regulatory requirements.After relocating from Ireland, my role at Viva Pharmaceutical Inc. became a crucial chapter in adapting to the Canadian professional landscape. This experience provided me with a solid foundation in navigating the intricacies of regulatory affairs and quality assurance in my new Canadian work environment.

In my final role at Kerry Group, I assumed the position of Regulatory Project Officer with a focus on project management. During this dynamic period, I spearheaded initiatives aimed at integrating internal data systems. My responsibilities encompassed the coordination and execution of projects to enhance data system efficiency within the regulatory domain. This role not only allowed me to showcase my project management skills but also contributed to the seamless integration of data systems, fostering a more streamlined and effective regulatory environment.

Transitioning into the role of Technical Information Officer for Finished Goods, with a focus on meats, I played a key role in ensuring compliance and meeting the stringent specifications of renowned customers, including McDonald's, Burger King, 2 Sisters Food Group, and Kerry Foods. My responsibilities encompassed the meticulous management of customer specifications, reflecting my dedication to maintaining the highest standards in regulatory affairs.

Elevated to the position of Technical Information Officer, Regulatory - Raw Materials, I was recognized for my exceptional attention to detail and hard work during my initial role as a Project Information Officer. In this capacity, I took charge of managing and enhancing supplier specifications for raw materials.

I played a pivotal role in supporting the Regulatory Affairs team at Kerry. Tasked with handling intricate administrative responsibilities, focused on project-related duties, particularly in raw materials. Despite the temporary nature of the role, my commitment to efficient project management and attention to detail contributed significantly to the team's success during this period.