Staff Clinical Affairs Specialist

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 organizations global clinical strategy.
• The role ensures compliance with FDA 21 CFR Parts& 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