Senior Clinical Development Scientist – Computed Tomography

About the role

The Clinical Development Scientist for our Computed Tomography business analyses clinical studies and protocols to ensure regulatory compliance, data integrity and strategic alignment while producing high‑quality clinical evaluation reports, study reports, regulatory submissions and scientific publications. The role also drives clinical development and market‑access strategies by generating evidence‑based insights, cultivating key opinion‑leader relationships and supporting innovative study designs.

Key responsibilities

• Collect, appraise and analyse clinical data related to medical devices.
• Write documentation such as Clinical Evaluation Reports (CERs) and Post‑Market Clinical Follow‑Up (PMCF) reports to support regulatory submissions.
• Collaborate with internal and external partners—including project owners, regulatory teams, statisticians, clinical consultants and agencies—to ensure comprehensive analysis of clinical evidence.
• Interpret and disseminate evidence, authoring Clinical Study Reports (CSRs), CERs, PMCF reports and facilitating timely publication of study results.
• Create procedures and workflows for the Clinical Development department.

Required profile

• 5+ years of experience in Clinical Affairs, Clinical Research or a similar role within the medical‑device, pharmaceutical or healthcare industry, delivering results on time, within budget and in compliance with SOPs and regulations.
• Strong knowledge of EU Medical Device Regulations, Good Clinical Practice (GCP) and ICH guidelines, with experience in clinical investigation design, biostatistics, research methodologies, literature databases and medical writing.
• Advanced degree (MSc, PhD, MD or PharmD) in biomedical sciences, life sciences, public health or a related field; experience authoring MEDDEV 2.7.1 Rev. 4 and MDR‑compliant CERs and PMCF documentation is a plus.
• Detail‑oriented, highly organised professional with excellent analytical, communication and project‑management skills, able to work with cross‑functional global teams and communicate fluently in English.

Required skills

• Statistical software
• Medical writing
• Clinical investigation design
• Biostatistics