Director, Clinical Affairs - Neuromodulation Strategy & Trials

Saluda Medical; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Saluda Medical seeks a Director of Clinical Affairs to lead the clinical study program, shaping research strategy and regulatory activities for a novel closed-loop neuromodulation system. You will manage planning, execution, and reporting across cross-functional teams to enable global market access and adoption of a Class III implantable therapy.

You will collaborate with R&D, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs and Quality to deliver high-quality evidence, while

Qualifications

• 10+ years direct clinical and regulatory experience in medical devices.

Responsibilities

• Develop and maintain the clinical quality system and data integrity.
• Create detailed program plans and drive execution toward objectives.
• Collaborate cross-functionally to ensure clinical programs meet regulatory requirements.
• Develop protocols, SAPs, reports and other clinical study documents.
• Support manuscripts, abstracts, data presentations and health economic initiatives.
• Lead issue identification and resolution across programs.

Skills

Clinical trial leadership

Regulatory strategy

Medical device experience

Data analysis

Regulatory filings

Neurostimulation knowledge

Education

Bachelor's in science/biomedical/health related field

Master's or PhD preferred

Tools

EDC systems

Clinical trial management software

Job description

Saluda Medical seeks a Director of Clinical Affairs to lead the clinical study program, shaping research strategy and regulatory activities for a novel closed-loop neuromodulation system. You will manage planning, execution, and reporting across cross-functional teams to enable global market access and adoption of a Class III implantable therapy.

You will collaborate with R&D, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs and Quality to deliver high-quality evidence, while