Staff Clinical Affairs Specialist

About the role

The Staff Clinical Affairs Specialist provides strategic quality oversight and operational support for global clinical programs, ensuring compliance with multiple regulatory frameworks and driving enterprise clinical initiatives.

Key responsibilities

• Oversee clinical quality activities including documentation review, audits of investigators, sponsors, CROs and vendors, CAPA management, risk assessments and inspection readiness.
• Serve as administrator/SME for enterprise clinical systems such as CTMS, EDC, eTMF, SharePoint, Azure DevOps and Power BI, handling user access, change management, training and governance.
• Collaborate with Clinical Global Process Owners to develop procedures, policies, knowledge repositories, dashboards and enterprise metrics, and support new regulatory requirements like EUDAMED.
• Evaluate clinical technologies and vendors, lead cross‑functional projects, facilitate global clinical forums and drive process standardisation across divisions.

Required profile

• 7‑9 years of experience in Clinical Quality, Clinical Affairs or Clinical Research within the medical device industry.
• Strong expertise in global regulations (FDA, EU MDR, ISO standards, ICH‑GCP) and experience with digital transformation initiatives.

Required skills

• CTMS
• EDC
• eTMF
• SharePoint
• Azure DevOps
• Power BI