Find jobs
Pricing
Free Resume Checker
Blog
Sign in
Sign up
FIND JOBSPRICINGFREE RESUME CHECKERBLOGSIGN INSIGN UP
Stryker

Staff Clinical Affairs Specialist

LocationGurugram, India
Work modehybrid
Typefull-time
SeniorityLead
Experience7–9 yrs
Company size10,000+ people
PostedJul 31, 2026 · 2mo ago
Verified live7h ago
At a glanceSummarised by Seekless from the posting.
Must have7
7 years - 9 years experience
5-8 years of experience in Clinical Quality, Clinical Affairs, or Clinical Research within the medical device industry
Strong expertise in global regulations (FDA 21 CFR Parts 50, 54, 56, 812 & 820, EU MDR 2017/745, ISO 14155, ISO 13485, ISO 14971, and ICH-GCP)
Expertise in clinical systems (CTMS, EDC, eTMF, SharePoint, Azure DevOps, Power BI)
Project management skills
Stakeholder engagement skills
Digital transformation initiatives experience
Skills
CTMS
EDC
eTMF
SharePoint
Azure DevOps
Power BI
Work Flexibility: Hybrid
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.
Travel Percentage: None
More roles at Stryker
Associate Territory Manager, Trauma WAMechatronics InternSales Representative - Jackson, MS - Orthopaedic InstrumentsDiscover Internship ProgramSales Representative, Trauma - Wales
Seekless
Seek less: one search across companies' own career pages, instead of a dozen job boards.
Product
Find jobsCompaniesPricingFree Resume Checker
Company
AboutBlog
Legal
PrivacyTermsCookies
© 2026 SEEKLESS. ALL RIGHTS RESERVED.BUILT WITH CARE