Manager, Clinical Affairs - Neurostimulation Trials

Saluda Medical Pty; Minneapolis (MN); On-site; USD 150,000 - 210,000; Full time

Job summary

Saluda Medical, a Minneapolis-based, commercial-stage medical device company, seeks a Manager, Clinical Affairs to lead its clinical study program and global regulatory activities.

You will shape the clinical research strategy and oversee planning, execution, and reporting in collaboration with R&D, Regulatory, and Medical Affairs to support market access for a novel class III implantable neuromodulation therapy.

Qualifications

• Bachelor’s degree in science/biomedical/health related field required; advanced degree preferred.
• 5+ years clinical and regulatory experience in medical devices.
• Experience with Active Implantable Medical Devices and FDA regulation desirable.

Responsibilities

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

Skills

Clinical trial design

Regulatory affairs

FDA regulatory experience

Neurostimulation (preferred)

Cross-functional leadership

Education

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

Masters or PhD preferred

Tools

EDC systems

Job description

Saluda Medical, a Minneapolis-based, commercial-stage medical device company, seeks a Manager, Clinical Affairs to lead its clinical study program and global regulatory activities.

You will shape the clinical research strategy and oversee planning, execution, and reporting in collaboration with R&D, Regulatory, and Medical Affairs to support market access for a novel class III implantable neuromodulation therapy.