Director, Clinical Affairs & Regulatory Strategy

Regulatory Toolkit; Minneapolis (MN); On-site; USD 180,000 - 240,000; Full time

Job summary

Saluda Medical seeks a Director, Clinical Affairs to lead the clinical study program and regulatory activities across global markets. You will define strategy, plan studies, manage regulatory interactions, and collaborate with R&D, Marketing, Clinical Operations, Medical Affairs, and Regulatory Affairs to enable market access for a novel class III implantable neuromodulation therapy.

You will drive execution, ensure data integrity, and contribute to manuscripts and health economic initiatives

Qualifications

• 10+ years direct clinical and regulatory experience in medical devices
• Bachelor’s degree; advanced degree preferred
• Experience in developing clinical evidence strategies and conducting clinical trials
• Experience with FDA and regulatory agencies
• Experience with neurostimulation industry preferred

Responsibilities

• Develop, maintain, and optimize the clinical quality system and regulatory requirements; ensure data integrity
• Create program plans and drive execution toward objectives; assess risk and strategies
• Contribute to strategic direction for clinical affairs objectives and processes
• Direct and collaborate with internal and external staff for successful clinical programs
• Develop protocols, SAPs, reports and other clinical study documentation
• Support manuscripts, abstracts, data presentations, and health economic initiatives
• Promote a high-performance culture and cross-functional collaboration
• Lead issue identification and resolution across programs

Skills

Clinical regulatory

Active implantables

FDA knowledge

Clinical trials design

Data synthesis

Education

Bachelor’s degree in science/biomedical/health

Masters or PhD preferred

Tools

EDC systems

Clinical trial management tools

Job description

Saluda Medical seeks a Director, Clinical Affairs to lead the clinical study program and regulatory activities across global markets. You will define strategy, plan studies, manage regulatory interactions, and collaborate with R&D, Marketing, Clinical Operations, Medical Affairs, and Regulatory Affairs to enable market access for a novel class III implantable neuromodulation therapy.

You will drive execution, ensure data integrity, and contribute to manuscripts and health economic initiatives