Quality and Regulatory Specialist t

Job description

Job Description We are seeking a detail-oriented and self-driven Quality and Regulatory Specialist to support and strengthen our quality and regulatory processes within a regulated medical device environment. This role is ideal for a Quality Management professional who takes initiative, operates independently, and thrives in structured, standards-based environments. If you naturally identify gaps, ask thoughtful questions, and take ownership of documentation accuracy and process alignment, you will excel in this role. You will work closely with cross-functional teams to maintain controlled documentation, support compliance with applicable standards, assist with gap assessments, and contribute to continuous improvement initiatives. The ideal candidate is highly organized, confident navigating ISO requirements, and comfortable working with a high level of precision and accountability. Experience working within ISO regulated environments, particularly ISO 13485 is required. The role is hands-on and requires onsite work in Kitchener, Ontario. What You’ll Do: - Support communications with relevant regulatory bodies in North America and the EU to support clinical trials and device licens...