Senior Product & Program Manager, SaMD & Digital Therapeutics - Remote

Overview

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.

In Short

• Join a healthtech startup focused on digital care for sleep.
• Manage complex product and program lifecycles in a regulated environment.
• Deep understanding of FDA requirements and QMS systems is essential.
• Take ownership of a game-changing product impacting global health.
• Work on a product that will undergo FDA 510(k) clearance.
• Opportunity for substantial responsibility and autonomy.
• Flexible vacation time and hours offered.
• Comprehensive medical, dental, and vision coverage.
• Matching 401(k) and wellness reimbursement available.
• Remote or hybrid work policy in place.

Requirements

• Bachelor's degree in Engineering, Computer Science, or related field.
• 5+ years of experience in product/program management in regulated health tech.
• Experience with agile methodologies and software development processes.
• Deep knowledge of FDA regulations and 510(k) clearance processes.
• Proven experience with cross-functional teams in product development.
• Experience with clinical trials and integrating clinical data into development.
• Strong technical acumen for translating requirements into product plans.
• Excellent communication skills for leading teams and guiding discussions.
• Passion for making a difference in health and wellness.
• Start-up experience preferred.

Benefits

• Flexible vacation time and hours.
• Comprehensive medical, dental, and vision coverage.
• Matching 401(k) and wellness reimbursement.
• Remote or hybrid work policy.
• Employee discounts and more.