Degree in life sciences, biomedical engineering, pharmacy, medicine, or health technology sciences (minimum Master's degree).
At least 3 years of experience in Clinical Affairs within the medical device industry
In-depth knowledge of applicable regulations (ISO 14155, MDR 2017/745, GCP…)
Strong project management skills with the ability to lead multiple projects simultaneously
Writing, analysis and synthesis skills
Bonus: experience working in a startup environment.

Key Responsibilities

Planning and Management of Clinical Studies

Define and execute the clinical strategy in accordance with regulatory requirements (US, EU)
Design, plan, and oversee clinical investigations (pre- and post-marketing) in compliance with regulatory requirements (ISO 14155, MDR 2017/745, GCP…)
Collaborate with cross-functional teams (Top Management, R&D, Regulatory Affairs, Quality Assurance) to align clinical activities with product development goals
Manage relationships with investigators, ethics committees, regulatory authorities, CROs, and other partners/service providers
Coordinate the selection of investigation centers
Monitor Post-Market Clinical Follow-up (PMCF) activities to ensure continuous compliance.

Clinical Documentation and Regulatory Compliance

Lead the preparation, review, and submission of clinical documentation, including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Investigator Brochure, clinical protocols, and other clinical documentation.
Oversee the submission of clinical studies to regulatory agencies and ethics committees, in compliance with U.S. and EU regulatory guidelines
Ensure all clinical documentation adheres to the highest standards of regulatory clarity, scientific accuracy, and quality.
Ensure compliance with GDPR requirements regarding patient data management
Monitor and analyze clinical data in collaboration with medical and statistical teams.

Who We Are

Chipiron is revolutionizing the medical imaging industry by developing light and easily deployable MRI machines powered by an ultra-sensitive quantum detection system. Our mission is to make MRI accessible to everyone, everywhere. We're a team of engineers based in the heart of Paris, and we have only one obsession: building things people want.

Our Culture

Collaborative Decision-Making;
High Standards and Autonomy: We maintain high expectations for our team members and offer complete autonomy, coupled with incentives tied to the company's success, fostering a culture of ownership and accountability;
Value of Humility: We prioritize seeking the truth over being right;
English-First International Team.

Locations: The Ark
Remote status: Hybrid