Join Vitaliti Technologies Inc. as a Regulatory Specialist in Kitchener, Ontario, focusing on quality management within the medical device sector. This hands-on role requires a keen eye for documentation accuracy and process alignment.
Looking for a Quality and Regulatory Specialist with over 5 years of experience in regulated quality environments, preferably in medical devices. You will be responsible for upholding ISO 13485 standards and working closely with cross-functional teams to enhance compliance processes. This role is pivotal for ensuring documentation accuracy and supporting continuous improvement initiatives.
Key Responsibilities: • Communicate with relevant regulatory bodies for clinical trials • Maintain and oversee quality processes like device assembly • Ensure QMS processes comply with Health Canada, FDA, CE standards • Collaborate with R&D to align design with regulatory requirements • Support audits and assess c...