Senior Staff Regulatory Affairs Specialist

Senior Staff Regulatory Affairs Specialist

Stryker

Lund, Sweden

Responsibilities

  • As QMS Process owner responsible for:
    • Maintenance and continuous improvements of the Jolife Quality Management System. Drive development and or modification to the QMS for owned processes;
    • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements) for owned processes;
    • QMS-administration - handle change order, QMS originals and distribution;
    • Perform gap analysis for new or updated regulatory requirements and identify potential gaps in Jolife QMS.
  • Responsible for execution of new product registrations;
  • Responsible for Radio equipment registrations;
  • Responsible for Monitoring and Maintaining current product registrations;
  • Responsible for documented regulatory strategy and plan in NDP and sustaining projects;
  • Project managing of Projects related to the Regulatory Affairs field;
  • Ensure compliance with applicable regulatory requirements (EU Directives etc.);
  • Assess regulatory impact of Product Changes and execute notifications;
  • Monitoring of changing global regulatory requirement;
  • Regulatory Subject Matter Expert for product labeling, incl. UDI handling;
  • Regulatory Market support;
  • Maintain regulatory documents library and keep it current;
  • Prepare regulatory related data for Management reviews.

Competence Requirements

  • General competence requirements of 1.1;
  • University degree (or of an equivalent course of study) in natural sciences, medicine, pharmacy, engineering or another relevant discipline;
  • 7+ years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
  • Documented knowledge in the national regulatory requirements to which Jolife QMS shall comply (European Union, USA, Canada, Japan, Australia, Brazil, Korea etc.);
  • Solid analytical skills, fluent in writing (English) and MS Office;
  • Project Management Skills.

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EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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