**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 current 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** **y** **ears 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.
Stryker Corporation is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer – M/F/Veteran/Disability.

Required Skill Profession

Other General

📌 Staff Clinical Affairs Specialist (Gurugram)
🏢 Stryker
📍 Gurugram