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Senior Product & Program Manager, SaMD & Digital Therapeutics Ozlo. 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. Backed by venture funding, our crowdfunding campaign 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 that will set the stage for market success. You can see a one-minute 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. This is an exciting opportunity for someone to take full ownership of a game-changing product that is poised to make a significant impact on the health and well-being of millions of people around the world. . What’s In It For You:. If you’re seeking a meaningful challenge and want to work on a product that will have a tangible impact on people’s health, Ozlo is the place for you. As an early team member, you’ll have substantial responsibility and autonomy in shaping the architecture and regulatory strategy for our first SaMD product and driving it through FDA 510(k) clearance. Plus, as part of a high-growth startup, you’ll have the opportunity to share in any future financial upside through employee stock options. . Equal Opportunity Employer:. We are proud to be an Equal Opportunity workplace and an Affirmative Action employer. We are committed to equal employment opportunity regardless of age, race, color, religion, sex, ancestry, national origin, citizenship, sexual orientation, marital status, disability, gender identity, veteran status, or other applicable legally protected characteristics. . Benefits:. . Flexible vacation time and hours . Comprehensive medical, dental, and vision coverage (company pays premiums for employees and qualified dependents) . Matching 401(k) . Disability and group life insurance . FSA coverage . Wellness reimbursement . Remote or hybrid work policy . Employee discounts . And more!. 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 (clinical, regulatory, engineering, etc.) 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 for both regulatory compliance and to guide iterative improvements. . 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 in Healthcare, Regulatory Affairs, Biomedical Engineering, or related fields (preferred). . 5+ years of experience in product and/or program management, with a strong focus on SaMD, medical devices, or regulated health tech products that are governed by medical device standards such as ISO 13485 or similar quality management systems. . Experience with agile methodologies and other software development processes. . Deep knowledge of FDA regulations, including 510(k) clearance processes, SaMD guidelines, and relevant international regulatory frameworks (e.g., CE marking, MDR). . Strong familiarity with regulatory submissions, risk management, and product validation processes in the healthcare or medical device space. . Proven experience working with cross-functional teams (engineering, design, clinical, legal and regulatory) to drive the development of FDA-compliant products from ideation through market launch and maintenance. . Experience with clinical trials and/or real-world evidence collection and how to integrate clinical data into product development. . Solid understanding of software product lifecycle management, particularly for regulated digital health products (from early design through development, testing, regulatory approval, and post-market monitoring). . Strong technical acumen with the ability to translate complex hardware and software requirements into actionable product plans. . Ability to manage risk and make data-driven decisions to prioritize features, ensuring product quality and regulatory compliance. . Excellent communication skills, both written and verbal, with a proven track record of leading teams, aligning stakeholders, and guiding regulatory discussions. . Passion for making a difference and changing the world.