Director Of Quality & Regulatory Compliance

Who we are

Realize Medical is a medical virtual reality company based in Ottawa, Canada, and the creator of Elucis, a first-of-a-kind medical modeling and advanced visualization platform based entirely in virtual reality. Elucis was built for radiologists, surgeons, and other physician specialists with a need for 3D visualization of their patients’ anatomy with high anatomic fidelity.

We need your help to realize our vision of improving patient care by giving physicians, surgeons, and other healthcare professionals x-ray vision! When our customers say “if we could have done it this way from the start, we never would have done it any differently”, we know Elucis is set to transform healthcare.

Who we’re looking for:

An experienced Regulatory Affairs and Compliance Specialist to join our dynamic product development team to play a critical role in ensuring our suite of software medical devices meet global regulatory requirements and comply with all applicable standards. Oversight of product testing activities will also be a core part of the mandate.

As the Director of Quality & Regulatory Compliance, you will:

• Assist with the development and implementation of the company regulatory strategy
• Organize, conduct and document product testing activities with the dev team
• Monitor regulatory trends and changes to applicable regulations
• Report to the CPO and working closely with the CEO and other product owners
• Engage with regulatory agencies and auditing agencies to facilitate timely approvals
• Provide training to company personnel on regulatory topics and updates
• Prepare, submit and manage regulatory filings
• Ensure cohesion between product labelling, marketing, and promotional materials
• Conduct internal audits and maintain QMS documents and records

Ideally you:

• Are familiar with product development and project management
• Understand regulatory standards and medical device regulations in the US, Canada, and Europe
• Have a Bachelor’s degree in Life Sciences, Engineering, or a related field
• Are located in Ottawa for occasional meetings at our office location

Why should you join our team?

We are a highly collaborative team that values honesty and transparency.Working with us means contributing and discussing creative ideas among peers, working hard towards new solutions to unknown problems, and working in a high trust environment of freedom and responsibility. We provide a generous start-up compensation package of salary and stock options, open vacation and sick day policy, and flexible remote working options.