Manager, Clinical Affairs

🔥 11 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 11%

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Saluda Medical

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Saluda Medical is a pioneering company in the field of neuromodulation, focused on developing innovative platforms to treat chronic neurological conditions. They have created the Evoke® System, powered by their proprietary SmartLoop™ technology, which is designed to measure patients' unique biomarkers and continuously adjust stimulation to maintain therapeutic consistency. Saluda Medical is leading the way in transforming patient care through groundbreaking research and development, and their systems are widely recognized for their advanced capabilities in spinal cord stimulation therapy.

📋 Description

• Contribute to formulating the clinical research and evidence generation strategy • Plan, implement, manage, and report applicable clinical studies and associated regulatory activities • Collaborate with Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and Operations • Enable global market access and adoption of a Class III implantable electrical stimulation therapy • Drive program execution to meet customer needs and financial goals • Create and uphold a high-performance culture centered on customer focus, creative problem solving, transparency, and partnership • Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity/quality • Establish detailed program plans and drive execution toward established objectives • Assess risk and implement strategies to ensure successful delivery of clinical objectives • Direct and collaborate with internal and external staff and liaise with partner sites and physicians • 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 value initiatives • Lead issue identification and resolution

🎯 Requirements

• 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 devices and/or pharmaceuticals • Experience with neurostimulation industry preferred • Experience working with FDA and/or other regulatory and governmental agencies desired • Experience synthesizing complex clinical data into understandable written format • A minimum of a Bachelor’s degree in science, biomedical, or health-related field • Masters or PhD preferred • Ability to work effectively across time zones and cultures • Ability to travel domestically (10% of time) and internationally • Excellent verbal and written communication • Knowledge of ICH/GCP and FDA medical device regulations • Knowledge of research design, data analysis, and biostatistics • Ability to develop good interpersonal relationships with medical professionals • High degree of personal integrity • Excellent organizational skills and attention to detail • Self-motivated and independent work style with the ability to initiate and follow through on assignments • Knowledge of electronic data capture systems and web-based clinical trial management tools • Ability to think creatively and dynamically and foster a culture of commitment to thoughtful science

🏖️ Benefits

• Ability to work effectively across time zones and cultures • Ability to travel domestically (10% of time) and internationally • Diversity and equal opportunity workplace commitment

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