Clinical Affairs Lead, Medical Devices & Neuromodulation

Saluda Medical; Oregon; Hybrid; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Saluda Medical is seeking a Manager, Clinical Affairs to lead the planning, execution and reporting of pivotal clinical studies supporting the Evoke System. You will develop and maintain the clinical quality system and coordinate with cross-functional teams to ensure alignment with regulatory expectations.

The role requires extensive clinical/regulatory experience in medical devices, including neurostimulation, and involves collaboration with R&D, Regulatory Affairs, Medical Affairs, and

Qualifikationen

• 5+ years direct clinical and regulatory experience in medical devices including some experience with Active Implantable Medical Devices.
• Demonstrated success in designing and conducting clinical trials in support of medical device and/or pharmaceuticals.
• Experience with neurostimulation industry preferred; experience working with FDA and/or other regulatory agencies desired.
• A minimum of a Bachelor's degree in science/biomedical/health related field; Masters or PhD preferred.
• Ability to travel domestically (10% of time) and internationally.

Aufgaben

• Development, maintenance, and optimization of the clinical quality system, clinical regulatory requirements, and data integrity/quality.
• Establish detailed program plans, drive program execution toward established objectives, assess risk and implement strategies to ensure successful delivery of the clinical objectives.
• Direct and collaborate with internal and external staff, and liaise with partner sites and physicians, to ensure successful conduct of assigned clinical programs consistent with company objectives and applicable regulations and policies.
• Development of protocols, statistical analysis plans, reports and other clinical study documentation.
• Contribute to the overall strategic direction for development and implementation of clinical affairs objectives and processes.
• Support and contribute to manuscripts, abstracts, data presentations, and health economic value initiatives.
• Promote and embody culture and behavior expectations of a high-performance culture.
• Drives leadership of issue identification and resolution.

Kenntnisse

Clinical regulatory experience

Medical devices

Clinical trials design

FDA regulations

Neurostimulation

Ausbildung

Bachelor's degree in science/biomedical/health related field

Masters or PhD preferred

Tools

EDC systems

CTMS

Jobbeschreibung

Saluda Medical is seeking a Manager, Clinical Affairs to lead the planning, execution and reporting of pivotal clinical studies supporting the Evoke System. You will develop and maintain the clinical quality system and coordinate with cross-functional teams to ensure alignment with regulatory expectations.

The role requires extensive clinical/regulatory experience in medical devices, including neurostimulation, and involves collaboration with R&D, Regulatory Affairs, Medical Affairs, and