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Senior Regulatory Affairs Specialist (fixed-term contract until October 2027)
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Stryker

Senior Regulatory Affairs Specialist (fixed-term contract until October 2027)

Onsite Warsaw, Poland Junior
Posted a day ago
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Job Details

What You Will Do:

Watch this video to learn more about Stryker

  • 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.
Company Details
Stryker
 Kalamazoo, MI, United States
Work at Stryker

Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative... Read more

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