Staff Clinical Affairs Specialist

Stryker; Gurugram District; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Stryker is seeking a senior professional to provide strategic quality oversight and operational support for global clinical programs. The role focuses on ensuring compliance with FDA/EU/ISO regulations and partnering across Clinical Affairs, Regulatory, R&D, IT, Legal, and CROs to advance enterprise clinical initiatives.

The incumbent will oversee clinical quality activities, lead audits and CAPA management, manage risk assessments, and drive process standardization while acting as SME for

Qualifications

• 7–9 years of experience in Clinical Quality, Clinical Affairs, or Clinical Research in the medical device sector.
• Strong expertise in global regulations and clinical systems, with governance and quality oversight responsibilities.
• Experience leading cross-functional projects, inspections readiness, CAPA management, and risk assessments.

Responsibilities

• Provide strategic quality oversight and operational support for global clinical programs.
• Ensure compliance with FDA/EU/ISO/ICh-GCP standards and partner with Clinical Affairs, Regulatory, R&D, IT, Legal, and CROs.
• Lead audits, CAPA processes, risk assessments, and inspection readiness; drive standardization across divisions.

Skills

Regulatory compliance

Clinical quality

Project management

Stakeholder engagement

Digital transformation

Cross-functional leadership

Tools

CTMS

EDC

eTMF

SharePoint

Azure DevOps

Power BI

Job description

• 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 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-

• 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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.