DigeHealth is pioneering advancements in gastrointestinal health monitoring through cutting-edge wearable technology. You will play a vital role in developing solutions for patients, researchers and physicians. This position offers an opportunity to use your expertise on impactful health tech innovation, contributing to better clinical outcomes and improved patient care. You will work closely with healthcare professionals, and a dynamic, fast-paced startup team, requiring independence, creativity, and a proactive approach to solving complex challenges.

Study Management

• Oversee design, initiation, execution, and closure of clinical trials, including study protocols, ethical submissions and timelines.
• Ensure studies are conducted in compliance with GCP, ICH guidelines, ISO 14155, and applicable regulatory standards.
• Manage relationships with clinical sites, investigators

‍Regulatory & Compliance

• Serve as subject matter expert on clinical and regulatory requirements for medical device products.
• Maintain up-to-date knowledge of evolving regulatory landscapes (FDA, EMA, MDR, etc.).
• Provide clinical expertise input for risk management

Data Collection

• Maintain close relationships with clinical stakeholders to support data collection and technical problem solving
• Work closely with data scientists to provide context and ensure data quality

• Bachelor’s/ Master's degree in Life Sciences, or equivalent professional experience. PhD qualification is a plus.
• Experience in clinical operations, or related roles within medical device or diagnostics industry.
• Hands-on experience managing data collection using wearables or active medical devices
• Strong understanding of GCP, ISO 14155, and regulatory frameworks (FDA, EMA, MDR).
• Proven track record in managing clinical studies from start-up through closure.
• Excellent project management and organizational skills, with the ability to handle multiple priorities.
• Strong communication and interpersonal skills for working with investigators, CROs, and cross-functional teams
• Experience in gastroenterology and/or chronic disease management is highly regarded
• Language: DigeHealth's working language is English. Other languages are a plus. ‍

Candidates should apply directly with CV and cover letter to hello@digehealth.ch