Director, Regulatory Affairs

Who Are We?

Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes.
This is precision cardiology, and we know it’s within reach.

What Will You Do?

The Overview

The Director of Regulatory Affairs will lead all of Prolaio’s regulatory efforts. This role is responsible for building and executing the regulatory strategy that ensures our products are cleared and we are compliant. This individual will work closely with the FDA and other agencies, manage submissions, and ensure Prolaio’s compliance with changing regulations. This is a key role that works across teams to help us bring safe, effective products to market.

The Specifics

• Collaborate cross-functionally to develop, initiate, and pursue regulatory strategy for all Prolaio products
• Maintain compliance with FDA regulations (e.g., 21 CFR 820, 21 CFR Part 11, 21 CFR 812, 45 CFR 164, etc.) across product development and post-market activities
• Lead 510(k) submissions and act as the primary contact with the FDA and other agencies
• Responsible for FDA establishment registration and device listing
• Responsible for GUDID and GS1 (or equivalent) accounts
• Responsible for approving labeling, marketing, and all other promotional materials for compliance within a regulatory and QMS environment
• Keep abreast of regulatory changes and advise internal teams on impact assessment
• Maintain accurate, organized records of all submissions and regulatory interactions and regulatory submission files and history
• Lead and grow the regulatory team, including managing external consultants
• Collaborate and coordinate with Quality, Clinical, and Data Science leadership to support product development and market readiness
• Demonstrated OUS MDR experience

Why Prolaio?

• Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology.
• Innovative Environment: You will be part of an organization doing something that’s never been done before.
• Professional Growth: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow.
• Collaborative Team: You will be part of a team of collaborative, curious, and committed individuals focused on the collective good, inclusiveness, scientific excellence, and advancing digital health for cardiology.

Who You Are?

• Bachelor’s degree in a scientific, engineering, or regulatory field (advanced degree is a plus)
• 7+ years of leadership experience in medical device regulatory affairs (CDRH)
• Direct FDA interaction experience in context of and 510(k) submission
• Leadership of 510(k) Submission Team a plus (preferred to have won a 510(k) clearance)
• Demonstrated command of FDA requirements and global standards
• Experience effectively leading project teams and working cross-functionally
• Understands the regulatory environment in which resides software-based (i.e., SaMD) or connected digital health medical devices, as well as electronic document control systems
• Demonstrates excellent communication skills (verbal and written)

Why You’ll Love Working Here

• Meaningful Compensation: Competitive salary, performance bonus, and equity so you can share in what we build.
• Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
• Flexible Spending Perks: HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
• Time to Recharge: Generous paid time off, sick leave, and company holidays.
• Family-First Benefits: Paid parental leave, caregiver leave, and support for growing families.
• Security & Peace of Mind: Company-paid life insurance and short- and long-term disability coverage.
• Plan for the Future: 401(k) plan to help you build long-term financial security.
• Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.

Starting Salary is at $160,000.00 (Exact Compensation may vary based on skills, experience, and location)

Prolaio is an Equal Opportunity Employer (EOE) that welcomes and encourages all applicants to apply regardless of age, race, color, religion, sex, sexual orientation, gender identity and/or expression, national origin, disability, veteran status, marital or parental status, ancestry, citizenship status, pregnancy or other reasons prohibited by law.