Regulatory Affairs Specialist

Job Description

<h3>Job Description</h3><p>Job Description<p><p><b>ABOUT THE COMPANY</b><br /></p><p>Our client is a well-established Canadian healthcare organization specializing in the development, manufacturing, and distribution of innovative medical devices and solutions that improve patient outcomes and support healthcare professionals. With a strong focus on quality assurance, compliance, and regulatory integrity, the company is committed to upholding the highest standards across all operations. They partner with hospitals, clinics, and global suppliers to bring safe, effective, and compliant medical technologies to market.<br /></p><p><br /></p><p><b>WHAT ARE THE PRIMARY RESPONSIBILITIES OF THE JOB?</b><br /></p><ul><li><b>Regulatory Licensing and Submissions:</b> Lead licensing efforts for medical device products in Canada and international markets. Prepare and manage regulatory submissions to Health Canada and other authorities. Support product classification, registration, and licensing for new product launches.<br /></li><li><b>Regulatory Compliance and Communication:</b> Monitor regulatory updates and ensure ongoing compliance with Health Canada, ISO, FDA, and EU MDR standards. Maintain accurate electronic documentation and support activities related to the company’s Medical Device Establishment License (MDEL).<br /></li><li><b>Problem Reporting and Recalls:</b> Assist with mandatory problem reporting, recalls, and communication with Health Canada and other regulatory agencies.<br /></li><li><b>Cross-Functional Collaboration:</b> Work closely with Quality Assurance, Product Development, and Supply Chain teams to ensure regulatory and quality requirements are met throughout the product lifecycle.<br /></li></ul><br />Requirements<p><b>WHAT DOES THE IDEAL CANDIDATE OFFER?<br /></b></p><p><b>Education & Training</b><br /></p><ul><li>Post-secondary education in Regulatory Affairs, Life Sciences, or a related discipline.<br /></li></ul><p><b>Work Experience & Accomplishments</b><br /></p><ul><li>2+ years of experience in regulatory affairs within the medical device industry.<br /></li><li>Experience with Health Canada medical device licensing and registrations (MDEL).<br /></li><li>Previous involvement in recall activities and regulatory communications is an asset.<br /></li></ul><p><b>Skills & Competencies</b><br /></p><ul><li>Strong understanding of Canadian and international regulatory frameworks (Health Canada, ISO 13485, FDA, EU MDR).<br /></li><li>Excellent analytical, organizational, and documentation skills.<br /></li><li>Ability to manage multiple priorities and meet deadlines in a fast-paced environment.<br /></li><li>High attention to detail with a commitment to accuracy and compliance.<br /></li><li>Exceptional verbal and written communication skills.<br /></li><li>Proficiency in Microsoft technology.<br /></li></ul><br />Benefits<p><b>WHAT YOU CAN EXPECT IN RETURN</b><br /></p><ul><li><b>A Collaborative Culture:</b> Work with a team dedicated to innovation and regulatory excellence.<br /></li><li><b>Compensation:</b> A 12 month contract and a salary aligned with your expertise. There may be an opportunity for a permanent position.<br /></li><li><b>Meaningful Impact:</b> Contribute to the success of medical devices that enhance lives globally.<br /></li></ul><p>If this is the ideal next step in your career, we encourage you to apply to help this Canadian company shape the future of healthcare innovation and regulatory excellence.<br /></p><p><br /></p><p>#medicaldevice #regulatoryaffairs #hiring #careers<br /></p><p><br /></p><br /></p></p>