Stryker
Senior Regulatory Affairs Specialist (fixed-term contract until October 2027)
Company
Role
Senior Regulatory Affairs Specialist (fixed-term contract until October 2027)
Location
Poland
Job type
Full time
Posted
9 hours ago
Salary
Job description
Work Flexibility: Hybrid
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.
Travel Percentage: 0%