Clinical Affairs Manager
machineMD - Who we are
Founded 5 years ago in Bern by an interdisciplinary team with a shared vision for a world where patients receive an accurate, fast, and early diagnosis of brain disorders, machineMD is a rapidly growing Swiss MedTech company focusing on oculometrics.
Join machineMD and be part of a dedicated team with focus on the diagnosis and monitoring of neurological disorders through neuro-ophthalmology. Our flagship device, neos™, is the world’s first neuro-ophthalmoscope, enabling fast, quantitative, and objective exams using VR and AI-driven eye tracking.
Tasks
The Role
As a Clinical affairs manager at machineMD, you’ll be part of a fast paced and solution oriented interdisciplinary team where communication channels are short and decision rights distributed. You will support the strategic execution of our clinical roadmap, ensure that machineMD’s clinical research projects run smoothly and take responsibility for setting up and managing the investigator initiated research framework.
Key Responsibilities- Operational management and oversight of clinical investigations, during set-up, conduct and until archiving;
- Submissions, amendments and regulatory reporting to ethics committees and regulatory authorities, including safety reporting, annual reports and other required submissions.
- Monitoring of company sponsored clinical investigations
- Manage clinical documentation in accordance with ISO 14155, MDR, and FDA requirements and ensuring completeness and maintenance of TMF (Trial Master File) including filing and uploading documents and performing ongoing quality checks/review;
- Coordinate data collection and analysis in collaboration with study sites
- Review, keep up to date and/or create Standard Operational Procedures (SOPs), Work Instructions and processes;
- Support regulatory submissions (e.g., FDA 510(k), CE technical files)
- Contribute to publications and scientific presentations
- Act as liaison between R&D, Quality, and Commercial teams to integrate clinical insights
- Completed Master’s degree (MSc) in a technical, natural or health science discipline or an equivalent qualification
- At least 3 years of experience in the field of clinical trials/investigations, ideally for diagnostic medical devices, Class IIa or Class IIb
- Experience with ophthalmology or neurology is a strong asset
- Proven track record of clinical trial management, preparation of documentation and submission to competent authorities.
- Excellent knowledge of regulatory requirements: MDR (2017/745) and MDCG guidance, Good Clinical Practice ISO 14155, FDA guidelines
- Communication: Strong interpersonal skills, with the ability to collaborate effectively with investigators and sponsor representatives.
- Open to travel if required (< 10%)
- Strong scientific understanding and solid experience in scientific writing and publishing are a plus
- Experience in clinical research, risk analysis and clinical study planning in the Medtech industry is a plus
- Hands-on mindset, proactive, structured with high level of organizational skills, detail-oriented and collaborative with enthusiasm for interdisciplinary collaboration
- Fluent in English, both written and spoken, German and French a plus
- Be part of a fast-growing Medtech startup shaping the future of brain diagnostics
- Work alongside top medical experts and innovative minds
- International environment with locations in Bern and Boston
- Flexible worktime with possibility for home-office (fix in-office day: Mondays) in a company where work-life balance is key to productivity
- A strong company culture based on the concept of Conscious leadership and self-leadership, integrating elements of holacracy, encouraging independence, commitment and responsibility
We welcome applications from all qualified individuals regardless of gender, age, background, or orientation