Stryker

Stryker

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

Company

Stryker

Role

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

Location

Poland

Job type

Full time

Posted

9 hours ago

Salary

Not disclosed by employer

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%

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