Senior Clinical Affairs Lead, Neuromodulation

Saluda Medical; Minneapolis (MN); On-site; USD 140,000 - 200,000; Full time

Job summary

Saluda Medical, a Minneapolis-based medical device company, seeks a seasoned clinical/regulatory leader to shape the clinical quality system and regulatory strategy. You will drive protocol development, data integrity, and collaboration with sites and physicians to ensure compliant clinical programs.

You will design and oversee protocols, analysis plans, and reports, while supporting manuscripts and health economics initiatives.

Qualifications

• 5+ years direct clinical and regulatory experience in medical devices.
• Experience with Active Implantable Medical Devices is a plus.
• Experience with FDA and regulatory agencies desired.
• Ability to translate complex clinical data into understandable written reports.

Responsibilities

• Develop, maintain, and optimize the clinical quality system, regulatory requirements, and data integrity/quality.
• Establish detailed program plans, drive execution, assess risk and ensure delivery of clinical objectives.
• Coordinate with internal/external staff, partner sites and physicians for compliant clinical programs.
• Develop protocols, statistical analysis plans, reports, and other clinical study documentation.
• Contribute to strategic direction for clinical affairs objectives and processes.
• Support manuscripts, abstracts, data presentations, and health economic initiatives.
• Promote a high-performance culture and drive issue identification and resolution.

Skills

Clinical regulatory

Medical device regulations

Data integrity

Cross-functional collab

Travel ready

Education

Bachelor’s degree in science/biomedical/health

Masters or PhD preferred

Job description

Saluda Medical, a Minneapolis-based medical device company, seeks a seasoned clinical/regulatory leader to shape the clinical quality system and regulatory strategy. You will drive protocol development, data integrity, and collaboration with sites and physicians to ensure compliant clinical programs.

You will design and oversee protocols, analysis plans, and reports, while supporting manuscripts and health economics initiatives.