Staff Clinical Affairs Specialist

Stryker; Gurugram District; On-site; INR 2,200,000 - 3,600,000; Full time

Job summary

Stryker in Gurugram, India, seeks a senior Clinical Quality lead to drive strategic quality oversight for global clinical programs and ensure regulatory compliance across standards such as FDA, EU MDR, and ICH-GCP.

You will manage audits, CAPA, risk assessments, and inspection readiness, while acting as SME for CTMS/EDC/eTMF/Power BI platforms and guiding system governance.

Qualifications

• 7–9 years of experience.
• 5–8 years of experience in Clinical Quality, Clinical Affairs, or Clinical Research within the medical device industry.

Responsibilities

• Provide strategic quality oversight and operational support for global clinical programs.
• Ensure compliance with FDA 21 CFR Parts 50, 54, 56, 812 and EU MDR 2017/745, ISO 14155, ISO 13485, ISO 14971, and ICH-GCP.
• Oversee clinical quality activities including audits, CAPA management, risk assessments, inspection readiness, and continuous quality improvement.
• Serve as administrator/SME for platforms such as CTMS, EDC, eTMF, SharePoint, Azure DevOps, and Power BI, including user access, training, and governance.
• Collaborate with Clinical Global Process Owners to develop procedures, policies, dashboards, and enterprise metrics; support new regulatory requirements like EUDAMED.
• Evaluate clinical technologies and vendors; lead cross-functional projects and drive process standardization across divisions.

Skills

Regulatory compliance

Quality management

Project management

Stakeholder engagement

Digital transformation

Tools

CTMS

EDC

eTMF

SharePoint

Azure DevOps

Power BI

Job description

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 years 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.