Staff Clinical Affairs Specialist

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, e TMF, Share Point, Azure Dev Ops, 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 Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.