Clinical Affairs Manager (H/F)

Overview

EOS imaging is an international company specializing in innovative imaging and software solutions for osteoarticular care and orthopedic surgery. It is part of the Alphatec Spine group. The key values of curiosity, pushing boundaries, and high clinical standards form the basis of collaborative work with a common goal: the best patient care. Proud of the products they develop, the EOS Imaging teams enjoy working in a friendly environment where everyone is committed to moving projects forward. Within the Clinical team of Atec and based in France, the EOS Clinical Affairs Manager will lead clinical performance testing and validation initiatives to support regulatory and post-market clinical activities for EOS imaging systems. This role requires clinical expertise in radiological devices (hardware and software) and performance evaluation, with a particular focus on clinical data generation to support 510(k) and CE marking activities. The successful candidate will collaborate closely with cross-functional teams, including Marketing, research teams within Scientific Affairs, Clinical Operations, Medical Writing, Research and Development, and Regulatory Affairs. This role includes managing a Clinical Affairs Engineer based in Paris.

Responsibilities

• Provide clinical expertise to the product development team, supporting EOS imaging hardware and software products, including strategic input on intended use, indications/contraindications, and end‑user perspective in collaboration with design surgeons.
• Define and execute clinical performance testing strategy for clinical validation of EOS products, including image quality, AI/ML‑based software functions, and other cutting edge projects.
• Design, plan, and manage clinical studies focused on the performance and validation of EOS imaging products in compliance with GCP, local regulatory requirements including MDR, CNIL and GDPR, and ethical standards.
• In collaboration with other Clinical team members, support clinical evaluation (CEPs, CERs) and post‑market surveillance activities.
• Oversee clinical documentation for CE mark and 510(k) submissions, including persuasive evidence summaries, technical just, and strategic writing to support regulatory approval.
• Clinical lead for creation and review of EOS marketing collateral.
• Maintain current knowledge of regulations and guidelines affecting clinical performance evaluation.
• Identify and build relationships with key opinion leaders (KOLs) to promote clinician collaboration on relevant projects, building and growing customer and investigator relationships that drive credibility in our products and organization.
• Contribute to the dissemination of scientific findings through presentation and writing for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, product/proural training and collateral; assist investigators or customers on the preparation and delivery of research results.
• Collaborate closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the research activities within the team.
• Perform other duties as required.

Qualifications

• Superior problem‑solving skills with a solid understanding of clinical performance evaluation.
• Ability to build and maintain mutually respectful relationships with clinicians and scientists.
• Medical imaging expertise, related to image quality and/or quantitative imaging software devices (image processing, bone densitometry).
• Knowledge of orthopedics research, particularly spine, is a plus.
• Strong knowledge of research study design, GCP, and regulatory requirements.
• Excellent communication skills, both verbal and written, to communicate internally and externally with investigators and customers.
• Ability to work effectively in a cross‑functional and dynamic team environment.
• Superior organization skills, attention to detail, and the ability to keep detailed, accurate records.
• Self‑motivation, self‑starter.
• Ability to exercise independent judgment consistent with department guidelines.
• Ability to learn and maintain knowledge of procedures, products, and activities of assigned area.
• Proficiency with common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required.
• Ability to travel as needed for conference and symposium support and physician engagement.

Education & Experience

• Minimum of Bachelor’s degree in a field of science required.
• Capacité à voyager en fonction des besoins pour soutenir les conférences et les symposiums et pour mobiliser les médecins.
• Une licence dans un domaine scientifique en lien avec la santé au minimum est requise.

Requirements

• Superior problem‑solving skills with a solid understanding of clinical performance evaluation.
• Ability to build and maintain mutually respectful relationships with clinicians and scientists.
• Medical imaging expertise, related to image quality and/or quantitative imaging software devices (image processing, bone densitometry).
• Knowledge of orthopedics research, particularly spine, is a plus.
• Strong knowledge of research study design, GCP, and regulatory requirements.
• Excellent communication skills, both verbal and written, to communicate internally and externally with investigators and customers.
• Ability to work effectively in a cross‑functional and dynamic team environment.
• Superior organization skills, attention to detail, and the ability to keep detailed, accurate records.
• Self‑motivation, self‑starter.
• Ability to exercise independent judgment consistent with department guidelines.
• Ability to learn and maintain knowledge of procedures, products, and activities of assigned area.
• Proficiency with common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required.
• Ability to travel as needed for conference and symposium support and physician engagement.