Job Information
Stryker Senior Regulatory Affairs Specialist (fixed-term contract until October 2027) in Warsaw, Poland
What You Will Do:
Support product notification and market access activities for Stryker Polska
Maintain accuracy of data in Stryker regulatory databases and in the local ERP system
Provide regulatory documentation to tenders, distributors and customers
Communicate regulatory changes, assess commercial impact of changes and discontinuations
Act as a primary regulatory partner to local Sales, Marketing, Tenders, provide training and regulatory guidance
Act as a primary regulatory partner to regional and divisional regulatory teams
Monitor evolving medical device and environmental regulations
Support post-market activities related to product complaints, holds and field actions
Support maintenance and audit readiness of local QMS
What You Need:
Required:
2 years of experience in the medical device industry
Knowledge of medical device quality management systems and regulatory compliance
English and Polish full professional proficiency
Communication and collaboration skills to foster connections with other teams.
Action-oriented with results-driven mindset
Attention to detail
Preferred:
Experience with NC/CAPA management
Experience with TrackWise
Salary information will be provided during the recruitment process.
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.