Manager Clinical Affairs

machineMD; Schoringen; Vor Ort; CHF 90’000 - 120’000; Vollzeit

Zusammenfassung

As a Clinical Affairs Manager at a rapidly growing MedTech company focused on innovative brain diagnostics, you will oversee the operational management of clinical investigations and ensure compliance with regulatory requirements. Join a dedicated team driving solutions in neuro-ophthalmology and contribute to groundbreaking advancements. This role offers a collaborative environment where your expertise will shape the future of patient diagnostics.

Leistungen

Flexible worktime with home-office options

Strong company culture emphasizing work-life balance

Qualifikationen

• At least 3 years of experience in clinical trials for diagnostic medical devices.
• Strong understanding of MDR and FDA guidelines.
• Fluency in English, German and French is a plus.

Aufgaben

• Operational management of clinical investigations from set-up to archiving.
• Monitor clinical documentation and ensure regulatory compliance.
• Act as liaison between R&D, Quality, and Commercial teams.

Kenntnisse

Regulatory requirements knowledge

Clinical trial management

Interpersonal skills

Scientific writing

Ausbildung

Master’s degree (MSc) in technical, natural or health science

Jobbeschreibung

Clinical Affairs Manager

Location: Bern, Switzerland

Department: Clinical & Medical Affairs

Employment: Full-time

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.

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

Your profile

• 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

Why Join Us?

• 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