[Remote] Senior Program Manager, SaMD at Oura

New York, New York, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Health TechnologyIndustries

Requirements

Candidates should possess a degree in Biomedical/Mechanical Engineering or a related technical/scientific discipline and have over 7 years of project/program management experience. Experience with Quality Management Systems, medical device regulations and standards, risk management, and medical device software development (IEC 62304) is required. Excellent leadership, interpersonal, collaboration, and communication skills are essential, along with the ability to understand and articulate the need for diligence in ensuring regulatory and standards compliance. Strong organizational, prioritization, and execution skills, with a detail-oriented approach, are also necessary.

Responsibilities

The Senior Program Manager will define project scope, goals, and deliverables in collaboration with various teams and stakeholders. They will develop project plans, coordinate cross-functional teams, and manage the preparation and submission of regulatory documents. The role involves monitoring program progress, identifying and mitigating risks, and serving as the primary point of contact for stakeholders. Responsibilities also include developing and managing project budgets, overseeing all phases of the Software as a Medical Device product lifecycle, resolving conflicts, and fostering a culture of continuous improvement.

Skills

Program Management

Medical Device Software

Regulatory Compliance

Project Planning

Risk Management

Stakeholder Communication

Cross-functional Team Coordination

Regulatory Document Submission

510(k)

PMA

CE Mark

Oura

Wearable health monitoring smart ring

About Oura

Oura offers a smart ring that tracks various health metrics, including sleep patterns, heart rate variability, and physical activity. The ring uses advanced sensors to collect data, which is then analyzed and displayed through a mobile app, providing users with insights to improve their health and lifestyle. Unlike many competitors, Oura focuses on a direct-to-consumer model, selling its rings through its website and collaborating with sports teams and health institutions for additional partnerships. The goal of Oura is to help users, including athletes and those with health conditions, optimize their health through data-driven insights.

Oulu, FinlandHeadquarters

2013Year Founded

$344.1MTotal Funding

SERIES_DCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees