Full-Time Senior Product & Program Manager, SaMD & Digital Therapeutics

Who We Are: Ozlo is a Boston-based healthtech startup dedicated to revolutionizing digital care for better sleep. Our innovative ecosystem of sleep solutions, including the award-winning Ozlo Sleepbuds®, harnesses sophisticated technology and sound to unlock restorative sleep. We are on a mission to improve the lives of millions globally, and we're scaling a next-generation version of an already successful consumer wellness product. This is a unique opportunity to join a team building a truly transformative experience for customers and, soon, patients. We're backed by venture funding, and our crowdfunding campaigns on Kickstarter and Indiegogo raised over $8M from nearly 30,000 backers, setting all-time records.

What We’re Building: As we advance our clinical trials and build out a next-gen hardware platform, we are also laying the foundation for a rigorous, FDA-compliant digital therapeutics platform. This platform will set the stage for market success. See a teaser of our near-term clinical ambitions here.

What We’re Looking For: We’re looking for someone who is not only adept at managing complex product and program lifecycles but also thrives in highly regulated environments, with a deep understanding of FDA requirements, QMS systems, and the unique challenges of digital health.

Responsibilities:

• Develop and execute the regulatory strategy for the SaMD product, ensuring compliance with FDA and international standards, and driving the submission process through 510(k) clearance.
• Work closely with internal and external experts to define product development timelines, ensure regulatory adherence, and drive innovation that meets both user needs and compliance standards.
• Develop and execute a roadmap for new product features, integrating both clinical needs and regulatory requirements.
• Manage the product lifecycle from initial concept through development, testing, regulatory submission, and approval under our Quality Management System.
• Continuously assess and document product performance, user feedback, complaint handling and clinical data.
• Build and maintain relationships with regulatory bodies, healthcare providers, and key external partners.
• Ensure that all product documentation meets regulatory standards and supports the successful clearance of new devices.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Life Sciences, or a related field (required).
• Master’s or equivalent work experience (preferred).
• 5+ years of experience in product and/or program management, with a strong focus on SaMD, medical devices, or regulated health tech products.
• Experience with agile methodologies and software development processes.
• Deep knowledge of FDA regulations, including 510(k) clearance processes, SaMD guidelines, and relevant international regulatory frameworks.
• Strong familiarity with regulatory submissions, risk management, and product validation processes.
• Proven experience working with cross-functional teams.
• Experience with clinical trials and real-world evidence collection.
• Solid understanding of software product lifecycle management.
• Strong technical acumen with the ability to translate complex requirements.
• Ability to manage risk and make data-driven decisions.
• Excellent communication skills.
• Passion for making a difference.

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