Gestionnaire senior coordonnant le portefeuille d’initiatives de sécurité numérique de Promutuel Assurance. Pilotage des feuilles de route, dépendances, risques, capacités et rapports exécutifs.
About the role
- Project Manager leading Genomadix medical device development and manufacturing transfers. Coordinating cross-functional R&D, quality, regulatory, operations, and company-wide initiatives.
Responsibilities
- Lead medical device projects from R&D development through design transfer and manufacturing transfer
- Plan and execute manufacturing transfers with Operations, Quality, Supply Chain, and Regulatory
- Partner with R&D to manage development timelines, milestones, and phase-gate reviews
- Manage company-wide projects across Quality, Regulatory, Commercial, Customer Success, and Finance
- Build and maintain project plans, schedules, budgets, risk registers, and status reports
- Coordinate with external partners and suppliers, including Asia-based projects requiring early-morning meetings
- Identify risks and dependencies early and drive mitigation and escalation
- Ensure project work complies with applicable regulations and standards, including ISO 13485, FDA 21 CFR Part 820, Health Canada, and IVDR
- Communicate progress, issues, and decisions to team members and leadership
Requirements
- Minimum 5 years of project management experience within a medical device PMO environment
- Demonstrated experience supporting manufacturing transfers and R&D product development
- Experience managing cross-functional projects across a variety of business functions
- Working knowledge of design controls, change control, and quality management systems
- Proficiency with project management tools and methodologies, including MS Project, Smartsheet, Waterfall, Agile, or hybrid
- Strong communication, organizational, and stakeholder management skills
- Bachelor's degree in Engineering, Life Sciences, Business, or a related field
- Available for regular early-morning meetings to support Asia-based projects
- Able to travel occasionally
- Preferred: In vitro diagnostics (IVD) experience; pharmacogenetics or molecular diagnostics experience
- Preferred: PMP or equivalent project management certification
- Preferred: Experience working with contract manufacturers
- Preferred: Familiarity with FDA 510(k)/De Novo, Health Canada medical device licensing, or IVDR
- Preferred: Experience working in a small or growing company
Benefits
- Full-time, permanent employment
- Hybrid work in Ottawa, ON or remote in Canada
- Occasional, minimal travel
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