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Saluda Medical
Manager Clinical Affairs
Remote · United States · Full time · Mid level
About the role
Lead Saluda's clinical study program, managing clinical research and regulatory activities. Collaborate cross-functionally to enable global market access for implantable electrical stimulation therapy.
What you’ll do
• Develop and optimize clinical quality system and regulatory requirements. • Establish and drive clinical program plans and risk strategies. • Collaborate with internal/external staff and partner sites. • Develop clinical study documentation and reports. • Support manuscripts, data presentations, and health economic initiatives.
What you’ll bring
• 5+ years clinical and regulatory experience in medical devices. • Experience with Active Implantable Medical Devices preferred. • Knowledge of FDA and regulatory agencies. • Bachelor’s degree in science/biomedical/health field required. • Ability to travel domestically and internationally.
Life at Saluda Medical
Culture focused on customer, creative problem solving, transparency, and partnership. Emphasizes high performance and integrity.
About Saluda Medical
Saluda Medical develops treatments for chronic neurological conditions using a novel closed-loop neuromodulation platform.