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

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Warsaw, 01-624, PL
Job details
Work flexibility: Hybrid Req ID: R562606 Employee type:
  • Temporary
  • Full Time
Job category: RAQA Travel: 0% Relocation: No

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Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Job description

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 and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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