Quality and Regulatory Expert at Vitaliti Technologies

Become a vital part of Vitaliti Technologies as a Quality and Regulatory Expert, focusing on medical device standards and compliance in Kitchener, Ontario. Utilize your deep expertise in ISO regulations and quality management systems.

In this role, you will support various regulatory tasks while ensuring the accuracy and compliance of documentation. Your 5+ years of experience in a regulated quality setting is essential for navigating complex quality management systems and collaborating with the R&D team to meet regulatory requirements. You must thrive in detailed, structured environments and excel in process improvement initiatives.

Key Responsibilities:

• Manage interactions with regulatory agencies for trials and licensing

• Maintain processes for quality assurance from assembly to release

• Ensure quality management documentation adheres to standards

• Administer workflows within the quality management system

• Conduct gap analysis and support audit processes

Requirements:

• Minimum 5 years in a regulated quality environment

• Bachelor's degree with P.Eng. certification preferred

• Knowledge of ISO 13485 and 9001

• Strong documentation and organizational skills

• Capability to work independently and deliver results

Bring your detailed approach and regulatory knowledge to strengthen Vitaliti’s commitment to quality in medical device production.
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