Director/Senior Director, Regulatory Affairs

HW3 is partnered with a rapidly growing medical technology company developing advanced systems and services that support transplant outcomes. The organization combines innovative devices, clinical evidence, and operational solutions to expand access to lifesaving transplant therapies.

Role Summary

The Director/Senior Director will lead regulatory strategy for clinical development and evidence generation across a portfolio of complex medical technologies. This role will guide regulatory pathways, oversee submissions, collaborate closely with Clinical Affairs, and engage global regulatory agencies to support product approvals, label expansions, and lifecycle management.

Key Responsibilities

• Lead global regulatory strategy for clinical programs, pre-market submissions, and post-market requirements.
• Partner with Clinical Affairs on trial design, evidence plans, and regulatory-clinical alignment.
• Drive major submissions (e.g., IDEs, PMAs, 510(k), international registrations) and manage interactions with regulators.
• Provide guidance on labeling, claims, risk management, and compliance for new and existing technologies.
• Monitor global regulatory trends and translate requirements into actionable strategies.
• Collaborate cross-functionally with R&D, Quality, Operations, and Commercial teams.
• Mentor regulatory staff and contribute to building scalable regulatory processes.

Qualifications

• Advanced degree in a scientific or engineering field preferred.
• 10–15 years of regulatory affairs experience with high-risk medical devices.
• Proven success leading major regulatory submissions and health authority interactions.
• Strong understanding of clinical evidence requirements and partnership with clinical development.
• Expertise in FDA, EU, and global medical device regulations and standards.
• Excellent communication, leadership, and cross-functional collaboration skills.