Clinical Device Quality Lead

We are supporting a leading global biopharmaceutical company in the expansion of its Clinical Development Devices Quality function. Following the success of an existing consultant within the team, a new position has been created to focus specifically on the clinical device quality scope.This role sits at the intersection of Clinical Operations, Quality, Regulatory Affairs, and external device vendors. The successful candidate will provide expert guidance on the selection, qualification, and quality oversight of medical devices used to collect clinical trial data, ensuring compliance with regulatory requirements and acceptance by health authorities.This is a highly consultative role where success is defined by influencing decisions early in the clinical development process rather than reviewing documentation after decisions have been made. Key ResponsibilitiesAct as the Quality representative for medical devices used within clinical development programs.Partner with Clinical Operations teams to evaluate device requirements for data collection within clinical trials.Assess and recommend suitable commercially available medical devices based on study objectives and data collection needs.Evaluate device manufacturers and vendors to ensure compliance with quality and regulatory standards.Lead or support vendor qualification and ongoing supplier oversight activities.Provide quality guidance regarding the acceptability of device-generated data for regulatory submissions.Ensure compliance with applicable regulations, standards, and internal quality requirements governing clinical investigations and medical devices.Support risk assessments associated with device selection and implementation.Collaborate closely with Regulatory Affairs, Clinical Development, Data Management, and external suppliers.Contribute to quality processes, procedures, and continuous improvement initiatives within the Clinical Development Devices Quality function.Support audits, inspections, and regulatory inquiries related to clinical development devices. Required QualificationsBachelor's, Master's, or equivalent degree in Life Sciences, Biomedical Engineering, Medical Devices, Quality Assurance, Regulatory Affairs, or a related discipline.Significant experience within Medical Device Quality, Clinical Quality, Development Quality, or Regulatory Affairs.Strong understanding of medical devices used within clinical development and clinical trials.Experience evaluating and qualifying medical device vendors and suppliers.Knowledge of applicable regulations and standards, including:ISO 13485GCP (ICH-GCP)MDR / IVDRFDA medical device regulationsRelevant clinical investigation requirementsExperience supporting cross-functional clinical development teams.Ability to assess whether devices and associated data are suitable for use in regulatory submissions.Excellent stakeholder management and communication skills. Preferred ExperienceExperience supporting clinical trials involving connected devices, wearable technologies, diagnostics, or patient monitoring systems.Direct experience interacting with regulatory authorities or supporting regulatory submissions involving device-generated clinical data.Experience working within pharmaceutical, biotechnology, or combination product environments.Previous involvement in inspection readiness, audits, or health authority interactions.