Quality and Regulatory Specialist

Cloud DX, Inc.; Kitchener; On-site; CAD 70,000 - 90,000; Full time

Job summary

Cloud DX, Inc. is seeking a detail-oriented Quality and Regulatory Specialist to enhance quality processes within the medical device sector.

The ideal candidate will support regulatory compliance, maintain controlled documentation, and engage in process improvement initiatives. Experience in ISO regulated environments is essential. This hands-on role is based in Kitchener, Ontario.

Qualifications

• 5+ years of experience in a regulated quality environment, especially in medical devices.
• Practical experience maintaining or supporting a Quality Management System.
• Knowledge of ISO 13485 and ISO 9001 requirements.

Responsibilities

• Support communications with regulatory bodies for trials and device licensing.
• Maintain quality processes including inspections and product releases.
• Ensure QMS processes conform to standards required for regulatory approval.

Skills

Attention to detail

Documentation control

Process organization

Communication skills

Education

Bachelor’s degree in engineering with P.Eng. designation

Job description

Vitaliti Technologies Inc. is creating an ecosystem of unique, proprietary medical devices and software that generate high frequency biological signals, feeding large volumes of structured data to our own machine learning & deep learning models. The key Vitaliti differentiator is the ability to gather very accurate telemetry from easy to use, continuous and spot monitor devices that can immediately be analyzed by modern artificial intelligence systems. Use cases include acute and chronic remote automated monitoring (RAM), hospital at home deployments and distributed clinical trials.

Job Description

We areseekinga 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,operatesindependently, and thrives in structured, standards-based environments. If you naturallyidentifygaps, 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 tomaintaincontrolled documentation, support compliance with applicable standards,assistwith gap assessments, and contribute to continuous improvement initiatives. The ideal candidate is highly organized,confidentnavigating ISO requirements, and comfortable working witha high levelof 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 licensing/clearance.
• Maintain internal quality processes, including shipping/receiving, incoming inspections, device assembly, and product releases.
• Be responsible forensuring that QMS processes and documentation conform to applicable standardsrequiredfor regulatory approval (Health Canada, FDA, CE)
• Administer andassistin the development of standards and workflows within the QMS
• Interface with the R&D team to ensure that PDLC processes and design principles fulfillanticipatedregulatory requirements
• Perform gap analysis between existing processes and documentation and manage the updating process
• Support internal and external audits.
• Assess compliance with standards and regulations andidentifyremedial actions where necessary
• Interface with Ethical Research Boards andparticipatingacademic or health institutions during studies and trials

Who You Are

• 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization
• Bachelor’s degree in engineering with P.Eng. designation
• Practical experiencemaintainingor supporting a Quality Management System
• Working knowledge of ISO 13485 and or ISO 9001 requirements
• Strong documentation control and process organization skills
• Demonstrated ability to work independently and drive tasks through to completion
• Strong attention to detail with the ability toidentifyinconsistencies or gaps in documentation
• Clear written and verbal communication skills
• Comfortable collaborating with technical teams in a structured environment

Job Location