Clinical Affairs Manager

Our client is an innovative cardiovascular medical device company developing advanced implantable technologies for the treatment of cardiac conditions. As they expand their clinical team, they are seeking an experienced Clinical Affairs Manager to support clinical development, clinical studies and the adoption of their technology across international markets.

The role

• You will work closely with cardiologists, electrophysiologists, KOLs, clinical sites and internal teams across Clinical, R&D, Regulatory and Quality.
• Managing clinical studies, sites, CRAs, CROs and external partners.
• Supporting study set-up, monitoring, clinical documentation and regulatory submissions.
• Developing and maintaining relationships with investigators and cardiovascular KOLs.
• Supporting clinical evidence generation, PMCF and clinical evaluation activities.
• Training physicians, hospital teams and external partners on cardiovascular medical devices.
• Providing clinical and technical support during procedures in cath lab and/or EP lab environments.
• Supporting device preparation, procedural workflows and troubleshooting.
• Gathering clinical feedback and working with R&D, Quality and Regulatory teams to improve device performance and usability.
• Supporting international clinical activities across Europe and the US.

Required experience

• Professional experience within the medical device industry.
• Strong cardiovascular/cardiology experience is essential.
• Experience within areas such as Cardiac Rhythm Management (CRM), pacemakers, electrophysiology, interventional cardiology, structural heart, heart failure or other cardiovascular technologies.
• Background in Clinical Affairs, Clinical Operations, Clinical Research and/or Clinical Applications.
• Experience working directly with cardiologists, electrophysiologists, investigators, KOLs and clinical sites.
• Experience with implantable and/or Class III medical devices is highly desirable.
• Knowledge of ICH-GCP, ISO 14155 and EU MDR.
• Experience managing clinical studies, sites, CRAs or CROs and/or providing clinical/technical support, physician training or procedural support in cath/EP lab environments.

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in technical and executive hiring across Medical Devices, Neurotechnology, AI, and DeepTech, partnering with innovative organisations across Europe, North America and Asia.