Project Manager coordinating AI device programs for Prenuvo's AI-enabled Software as a Medical Device initiatives. Collaborating with cross-functional teams and maintaining project documentation.
Responsibilities
Support project planning, scheduling and progress tracking for multiple AI device programs.
Collaborate closely with AI/ML engineers, systems engineers, regulatory affairs, product teams and clinical operations to keep deliverables synchronized across teams.
Maintain project documentation in Jira and other tools, track milestones and ensure all design control and regulatory deliverables are up to date.
Support readiness for regulatory submissions (such as 510(k), IDE, Health Canada) and plan/execute design control design reviews, including capturing clear summaries and follow-ups.
Provide regular updates on project progress, risks and dependencies to leadership.
Identify process gaps and contribute ideas to improve collaboration, documentation flow and delivery efficiency.
Requirements
Minimum of 2 years of experience coordinating projects in a healthcare environment.
Familiarity with medical device lifecycle management, especially Software as a Medical Device (SaMD) development and verification.
Excellent organizational and time management skills with strong attention to detail.
Ability to manage multiple priorities and deadlines in a fast-paced, cross-functional environment.
Strong written and verbal communication skills to bridge technical, regulatory and business teams.
Proficiency with project tracking tools (such as JIRA)
Bachelor’s degree in Biomedical Engineering, Project Management, or a related technical or business discipline.
Benefits
An avenue to make a positive impact on people's lives and their health
Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way
Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize
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