Regulatory Specialist in Medical Devices
Cloud DX • kitchener, Canada
Role Description
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...
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...