Senior Program Manager, SaMD

Oura is seeking an experienced Senior Program Manager, SaMD, to ensure compliance with standards and regulations for medical device software development. This role involves leading cross-functional teams, defining project scope, managing regulatory submissions, and mitigating risks throughout the product lifecycle. The ideal candidate will have a strong drive for quality and a desire to deliver impactful medical solutions globally.

Must Have

• Define project scope, goals, and deliverables with stakeholders
• Develop project plans, including timelines, resources, and budgets
• Coordinate cross-functional teams (TPMs, QA, regulatory, Science, Research Ops, legal)
• Manage preparation and submission of regulatory documents (510(k), PMA, CE Mark)
• Monitor program progress and adjust plans to meet objectives
• Identify, assess, and mitigate program risks (Value, Business, Feasibility, Usability, Regulatory)
• Serve as primary point of contact for stakeholders and facilitate communication
• Oversee all phases of SaMD product lifecycle in alignment with Design Controls and Regulatory pathway
• Drive product lifecycle phase reviews with the Product Manager
• Lead, mentor, and motivate program teams
• Resolve conflicts and remove obstacles to team progress
• Foster a culture of continuous improvement and high performance

Good to Have

• Deep knowledge and experience on software development in a regulated field
• Understanding of consumer software products

Perks & Benefits

• Competitive salary
• Lunch benefit
• Wellness benefit
• Flexible working hours
• Collaborative, smart teammates
• An Oura Ring of your own
• Occupational healthcare
• Wellness Time Off

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.

Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office.

We are looking for an experienced 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.

We’d love to have you in our office in Helsinki, but Oulu is an option also. This role requires moderate travelling, when Oura remote employees, and those in other major cities (like San Francisco and San Diego) occasionally get together.

Responsibilities:

While you are responsible for the technical project management, you also enjoy roll-up your sleeves and putting your hands in the mud. More specifically:

• 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.)
• Manage 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
• Allocate resources (personnel, equipment, budget) efficiently across multiple projects
• 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
• Drive product lifecycle phase reviews with the Product Manager
• Lead, mentor, and motivate program teams
• Resolve conflicts and remove obstacles to team progress
• Foster a culture of continuous improvement and high performance
• Perform a broad variety of tasks in support of the role and responsibilities.

Requirements:

We would love to have you on our team if you have a deep knowledge and experience on software development in a regulated field and ideally also understanding of consumer software products. More specifically:

• Degree in Biomedical/Computer Science or related technical or scientific discipline.
• Demonstrated ability to assess and provide technical guidance for software as a medical device (SaMD).
• Ability to grasp and bind holistic architecture across different contexts (App, cloud, IT, algorithms, FW,..)
• Demonstrated strong skills to organize, prioritize, and execute.
• Detail orientation with excellent leadership, interpersonal, collaboration and communication skills.
• Ability to sense and articulate why certain issues demand more diligence to ensure compliance to applicable regulations or standards.
• Experience with program risk management
• Understanding on regulatory inspections and interaction with regulatory authorities.
• 6+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820, ISO 13485:2016 and IEC 62304) as a program/project manager.

Benefits:

At Oura, we care about you and your wellbeing. Everyone here at Oura has a ring of their own and are continually looking to improve their health and add to our benefits!

What we offer:

• Competitive salary
• Lunch benefit
• Wellness benefit
• Flexible working hours
• Collaborative, smart teammates
• An Oura Ring of your own
• Occupational healthcare
• Wellness Time Off

If this sounds like the next step for you, please send us your application and CV as soon as possible by December 1st, 2025.

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.