PHARMAFull-time
Staff Clinical Affairs Specialist
By Admin · Quality Assurance & Quality Control
DELHI NCR (IN)HYBRIDPOSTED: 9/4/2026
PHARMAFull-time
HIRING ORGANIZATIONSTRYKERMedical Technology / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Provide strategic quality oversight and operational support for global clinical programs while driving enterprise clinical initiatives aligned with the organization's global clinical strategy.
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.
Partner with Clinical Affairs, Regulatory Affairs, R&D, Medical Safety, IT, Legal, Procurement, Data Management, and Clinical Research Organizations (CROs).
Oversee clinical quality activities including clinical-documentation review, investigator-site audits, sponsor audits, CRO and vendor audits, CAPA management, risk assessments, inspection readiness, and continuous quality improvement.
Clinical Systems & Digital Transformation
Provide functional and technical leadership for enterprise clinical systems.
Serve as administrator/subject-matter expert for CTMS, EDC, eTMF, SharePoint, Azure DevOps, and Power BI platforms.
Support user access, change management, training, system governance, and effective use of clinical technology platforms.
Process, Governance & Enterprise Initiatives
Collaborate with Clinical Global Process Owners (GPOs) to develop corporate procedures, clinical policies, knowledge repositories, dashboards, and enterprise metrics.
Support implementation of new regulatory requirements, including EUDAMED.
Evaluate clinical technologies and vendors and support selection/oversight activities.
Lead cross-functional projects and facilitate global clinical forums.
Manage stakeholder communications and drive process standardization across divisions.
Quality & Compliance Standards
Apply global medical-device clinical quality and regulatory requirements throughout clinical programs.
Maintain inspection readiness and support risk-based quality management.
Drive CAPA, audit, quality improvement, process governance, and standardization activities.
Integrate clinical operations, systems, data, regulatory, and quality requirements across global programs.
Company & Total Rewards
Stryker is a global medical-technology company operating across MedSurg, Neurotechnology, and Orthopaedics.
The company states that its total rewards package includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, service and performance awards, and location-specific social and recreational activities.
The role is full time and hybrid in Gurugram, with travel/relocation indicated as applicable.
REQUIRED VERIFIED SKILLS
Clinical Affairs
Clinical Quality
Clinical Research
Medical device industry experience
Global clinical regulations
FDA 21 CFR Parts 50 54 56 812 820
EU MDR 2017/745
ISO 14155
ISO 13485
ISO 14971
ICH-GCP
Clinical documentation review
Clinical audits
CAPA management
Risk assessment
Inspection readiness
Clinical systems
CTMS
EDC
eTMF
System governance
Project management
Stakeholder engagement
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
The supplied job posting does not disclose a specific salary range or fixed/variable compensation figures. It does state that Stryker provides a total rewards package that can include bonuses, healthcare, insurance benefits, retirement programs, wellness programs, service and performance awards, and location-specific social/recreational activities. Actual compensation should therefore be confirmed directly during the recruitment process and will depend on experience, role level, location, and company compensation practices.
ORGANIZATION CONTEXT & CULTURE
Stryker is one of the world's leading medical technology companies, offering a diverse range of innovative products and services. They specialize in Orthopaedics, Medical and Surgical (MedSurg), and Neurotechnology and Spine. The company works closely with medical professionals to deliver solutions that improve patient outcomes and hospital efficiency.
TEAM SIZE: 50,000+ employees
INDUSTRY: Medical Technology / Healthcare
EXPECTED CAREER ROADMAP
This Staff Clinical Affairs Specialist role provides a strong progression path across Clinical Affairs, Clinical Quality, clinical systems governance, regulatory compliance, and enterprise clinical operations within the medical-device industry. The combination of global clinical-program oversight, audit/CAPA responsibilities, regulatory expertise, clinical-system ownership, digital transformation, and cross-functional project leadership can support progression toward senior clinical affairs, clinical quality, clinical operations, global process-owner, clinical systems, or broader clinical strategy leadership positions. Exposure to enterprise initiatives and global stakeholders also creates opportunities to move into specialized quality, regulatory, clinical technology, or program-management leadership roles.
APPLICATION ADVISORY
Highlight 5–8+ years of medical-device Clinical Affairs, Clinical Quality, or Clinical Research experience. Make global regulatory expertise highly visible, especially FDA 21 CFR, EU MDR, ISO 14155, ISO 13485, ISO 14971, and ICH-GCP. Include measurable experience with audits, CAPA, risk assessments, inspection readiness, clinical documentation, CRO/vendor oversight, and quality improvement. Strongly emphasize hands-on knowledge of CTMS, EDC, eTMF, SharePoint, Azure DevOps, and Power BI if applicable. Demonstrate experience with clinical-system administration, governance, user access, change management, training, and digital transformation. Prepare examples of cross-functional leadership involving Clinical Affairs, Regulatory Affairs, R&D, Medical Safety, Data Management, Legal, IT, Procurement, and CROs. Be ready to discuss how you would manage regulatory changes, clinical quality risks, audit findings, CAPA, inspection readiness, and enterprise process standardization.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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