Director, Device Clinical Affairs

Role Summary

As Director of Device Clinical Affairs, you will lead the strategic and operational management of clinical programs for implantable medical devices. You will ensure studies meet the highest scientific, regulatory, and quality standards, overseeing multiphase development from startup to closeout. You will collaborate with Regulatory, Quality, Engineering, Medical Affairs, Marketing, and external partners to provide critical clinical evidence for regulatory submissions, labeling, human factors studies, and verification/validation activities. Your leadership will help bring innovative medical device solutions to market and improve patient care and outcomes.

Responsibilities

• Lead the execution of device clinical studies, ensuring compliance with applicable regulations and internal procedures.
• Manage relationships with subject matter experts, key opinion leaders, and investigators to support high-quality clinical data and submissions.
• Provide clinical input and oversight for regulatory strategy and submissions, including verification and validation activities.
• Oversee CRO relationships to ensure delivery against timelines, quality, and regulatory requirements.
• Ensure compliance of product labeling and promotional materials with regulatory requirements.
• Facilitate cross-functional alignment to achieve clinical program objectives.
• Address complex operational or protocol issues requiring senior clinical judgment.
• Travel to scientific meetings and clinical sites as needed, both domestically and internationally.

Qualifications

• Required: Bachelor's degree and a minimum of 12 years’ experience managing clinical studies. In lieu of required educational degree, candidates with a minimum of 6 years supervisory experience in a healthcare or clinical research setting with ACRP/SOCRA certification and a minimum of 4 years of relevant clinical research experience in a pharmaceutical device company/CRO may also be considered.
• Required: Experience with US FDA and European regulatory authorities.
• Required: High level of organizational and project management skills with ability to work collaboratively in a fast-paced, team-based matrix environment.
• Required: Excellent written and verbal communication skills.
• Required: Proven success in building relationships with stakeholders such as Clinical Operations, Regulatory, Biostatistics, and clinical investigators.
• Required: Ability to travel for scientific meetings and site visits as needed (domestic and international).
• Preferred: Master’s degree in life sciences, nursing, or related allied health profession.
• Preferred: Certification with ACRP/SOCRA or willingness to acquire.
• Preferred: Experience in a pharmaceutical device company or clinical research organization.