Staff Clinical Affairs Specialist

Job description

Work Flexibility: Hybrid What you will do- You will be responsible for providing strategic quality oversight and operational support for global clinical programs while driving enterprise clinical initiatives that support the organization's global clinical strategy. The role ensures compliance with FDA 21 CFR Parts 50, 54, 56, 812 & 820, EU MDR 2017/745, ISO 14155, ISO 13485, ISO 14971, and ICH-GCP , partnering with Clinical Affairs, Regulatory Affairs, R&D, Medical Safety, IT, Legal, Procurement, Data Management, and Clinical Research Organizations (CROs). The individual will oversee clinical quality activities, including review of clinical documentation, investigator site, sponsor, CRO and vendor audits, CAPA management, risk assessments, inspection readiness, and continuous quality improvement. In addition, the role will provide functional and technical leadership for enterprise clinical systems by serving as an administrator/SME for platforms such as CTMS, EDC, eTMF, SharePoint, Azure DevOps, and Power BI , supporting user access, change management, training, and system governance. The position will collaborate closely with Clinical Global Process Owners (GPOs) to develop corporate procedures, clinical policies, knowledge repositories, dashboards, and enterprise metrics, while supporting implementation of new regulatory requirements such as EUDAMED . Responsibilities also include evaluating clinical technologies and vendors, leading cross-functional projects, facilitating global clinical forums, managing stakeholder communications, and driving process standardization across divisions. What you will need- Required- Experience- 7 years - 9 years The ideal candidate will have 5-8 y ears of experience in Clinical Quality, Clinical Affairs, or Clinical Research within the medical device industry, with strong expertise in global regulations, clinical systems, project management, stakeholder engagement, and digital transformation initiatives. Travel Percentage: None