Senior Program Manager, SaMD - Remote

Overview

At Oura, our mission is to empower every person to own their inner potential. With our award-winning Oura Ring and app, we help over 2.5 million people turn insights about sleep, activity, and readiness into healthier, more balanced lives. We believe that starts from within — by creating a culture where our team feels supported, included, and inspired to do their best work. Our values guide how we show up for each other and our community every day.

We are looking for a Senior Program Manager to join the team to help us ensure we are compliant with the applicable standards and regulations governing the development of medical device software at Oura. This role will demand a sense of leadership and close collaboration across all stakeholders to ensure the software is developed, tested, documented, and delivered to meet defined requirements. We are seeking a candidate with a strong personal drive of quality, excellence, and motivated by the desire to deliver important medical solutions that can improve the lives of millions of people across the globe.

In Short

• Define project scope, goals, and deliverables in collaboration with Medical Device Team, Oura’s SaMD feature development team Product Manager, senior management and stakeholders.
• Develop project plans, including timelines, milestones, resource allocation, and budgets.
• Coordinate cross-functional teams (TPMs, quality assurance champions, regulatory, Science, Research Ops, legal, etc.).
• Coordinate preparation and submission of regulatory documents (510(k), PMA, CE Mark, etc.) with Regulatory Affairs and QAC.
• Monitor program progress and adjust plans as needed to meet objectives.
• Identify, assess, and mitigate program risks (Value, Business, Feasibility, Usability and Regulatory).
• Serve as the primary point of contact for stakeholders and facilitate communication between technical teams, business units, and external partners (CROs, etc.).
• Develop and manage project budgets; track expenditures and forecast future needs.
• Oversee all phases of the Software as a Medical Device product lifecycle (Context, Discovery, Development and Delivery) in alignment with the Design Controls and Regulatory pathway.
• Resolve conflicts and remove obstacles to team progress.
• Foster a culture of continuous improvement and high performance.

Requirements

• Strong leadership skills and ability to collaborate effectively.
• Experience in project management within the medical device sector.
• Knowledge of regulatory standards and compliance.
• Excellent communication skills for stakeholder engagement.
• Ability to manage budgets and resources effectively.
• Experience in risk assessment and management.

Benefits

• Opportunity to work with a mission-driven company.
• Collaborative and inclusive work culture.
• Flexible work arrangements including remote options.
• Access to cutting-edge technology and resources.
• Competitive salary and benefits package.