Director of Regulatory Affairs

About Urologic Health

Urologic Health is a clinical-stage medical device company developing a non-invasive, catheter-free urodynamic diagnostic system designed to transform the diagnosis of lower urinary tract disorders. The company is advancing toward U.S. FDA clearance and early commercialization.

Role Overview

Urologic Health is seeking a Director of Regulatory Affairs to lead and execute the company’s regulatory strategy, with a primary focus on achieving FDA 510(k) clearance. This is a hands-on leadership role suited for a regulatory professional with direct startup experience, including ownership of at least one successful FDA 510(k) submission.

Key Responsibilities

Regulatory Strategy and Execution

·      Lead the FDA 510(k) submission from regulatory strategy through clearance

·      Define regulatory pathway, predicate device strategy, and submission structure

·      Serve as primary point of contact with the FDA, including Pre-Sub/Q-Sub meetings and responses to FDA questions

·      Support global regulatory strategy as needed (e.g., CE/MDR readiness)

·      Regulatory Documentation and Submissions

·      Author, compile, and review regulatory submissions and supporting documentation, including:

§ FDA 510(k) dossiers

§ Risk management files (ISO 14971)

§ Clinical evidence and performance summaries

§ Labeling, Instructions for Use (IFU), and claims support

• Ensure consistency and alignment across regulatory, clinical, and technical documentation

Cross-Functional Leadership

·      Work closely with R&D, Clinical, and Quality teams to ensure regulatory requirements are integrated throughout development

·      Support design controls, verification and validation, and audit readiness

·      Manage and coordinate external regulatory consultants and notified bodies

Regulatory Readiness and Company Growth

·      Establish scalable regulatory processes appropriate for an early-stage medical device company

·      Support regulatory diligence for investors, strategic partners, and potential acquirers

·      Contribute to the long-term regulatory roadmap as the product portfolio expands

Required Qualifications

·      Minimum of 10 years of regulatory affairs experience in medical devices

·      Proven, hands-on experience leading at least one FDA 510(k) submission from a startup company (mandatory)

·      Strong working knowledge of FDA medical device regulations (21 CFR, guidance documents)

·      Experience with clinical-stage or early commercial medical devices

·      Excellent technical writing and regulatory documentation skills

·      Ability to work independently in a fast-paced, resource-constrained startup environment

Preferred Qualifications

·      Experience with diagnostic and/or urology devices

·      Experience with non-invasive monitoring or sensor-based technologies

·      Familiarity with FDA expedited programs (e.g., Breakthrough Devices, STeP)

·      Experience supporting CE/MDR submissions

·      Experience supporting regulatory diligence during fundraising or strategic transactions

Role Characteristics

·      Hands-on, execution-focused leadership role

·      Opportunity to build and own the regulatory function

·      Not a purely advisory or maintenance role

Think you’re a good fit? Please send you CV to [email protected]