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Quality Regulatory Specialist at Vitaliti TechnologiesCloud DX Inc • Winnipeg, Canada
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Quality Regulatory Specialist at Vitaliti Technologies

Quality Regulatory Specialist at Vitaliti Technologies

Cloud DX Inc • Winnipeg, Canada
12 days ago
Job type
  • Full-time
Job description
Enhance regulatory and quality processes at Vitaliti Technologies as a Quality and Regulatory Specialist. This hands-on role requires expertise in ISO standards and a focus on continuous improvement.

Vitaliti Technologies is seeking a driven Quality and Regulatory Specialist to strengthen its operations in Kitchener, Ontario. With over five years of experience in regulated environments, you'll navigate ISO 13485 requirements and support compliance across various processes. This role involves working closely with cross-functional teams to maintain documentation accuracy and ensure adherence to regulatory standards.

Key Responsibilities: • Support communications with regulatory bodies in North America and EU • Maintain internal quality processes for device assembly and product releases • Ensure QMS processes align with regulatory approval standards • Administer and develop workflows within the QMS • Conduct gap analyses for process documentation

Requirements: • 5+ years in regulated quality environments, ideally medical devices • Bachelor’s degree in engineering with P.Eng. designation • Strong knowledge of ISO 13485 and ISO 9001 • Proven organizational skills in documentation control • Effective communication skills with technical teams

Drive quality assurance and regulatory compliance at Vitaliti Technologies while enhancing your expertise in medical device standards. #J-18808-Ljbffr
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Quality Regulatory Specialist at Vitaliti Technologies • Winnipeg, Canada

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