Staff Clinical Affairs Specialist

About the role

Stryker is hiring a Staff Clinical Affairs Specialist in Gurugram on a hybrid basis. The role provides strategic quality oversight and operational support for global clinical programs, drives enterprise clinical initiatives aligned with the organization's global clinical strategy, and partners with Clinical Affairs, Regulatory Affairs, R&D, Medical Safety, IT, Legal, Procurement, Data Management and Clinical Research Organizations (CROs).

Key responsibilities

• Oversee clinical quality activities: review of clinical documentation, audits of investigator sites, sponsors, CROs and vendors, CAPA management, risk assessments, inspection readiness and continuous quality improvement.
• Ensure compliance with FDA 21 CFR Parts 50, 54, 56, 812 and 820, EU MDR 2017/745, ISO 14155, ISO 13485, ISO 14971 and ICH-GCP.
• Provide functional and technical leadership for enterprise clinical systems as administrator/SME of platforms such as CTMS, EDC, eTMF, SharePoint, Azure DevOps and Power BI, covering user access, change management, training and system governance.
• Work with Clinical Global Process Owners (GPOs) to develop corporate procedures, clinical policies, knowledge repositories, dashboards and enterprise metrics, and support implementation of new regulatory requirements such as EUDAMED.
• Evaluate clinical technologies and vendors, lead cross-functional projects, facilitate global clinical forums, manage stakeholder communications and drive process standardization across divisions.

Required profile

• 7 to 9 years of experience; the ideal candidate has 5 to 8 years in Clinical Quality, Clinical Affairs or Clinical Research within the medical device industry.
• Strong expertise in global regulations, clinical systems, project management, stakeholder engagement and digital transformation initiatives.
• No travel required.