Associate Director, Combination Product/Medical Device Compliance Specialist

Associate Director, Combination Product/Medical Device Compliance Specialist

Teva

Zagreb, Croatia

Your responsibilities

  • Input, Review, and Endorsement of Core Activities for Combination Products and Medical Devices throughout Product Lifecycle: Development, Launch, and Commercialization;
  • Engage in Corporate Standards Processes;
  • Input, Review, and Endorsement of Complex Investigations;
  • Support the Implementation of the Site Inspection Readiness Program;
  • Evaluate and Endorse the Site Inspection Readiness Program;
  • Review and Endorse the Site Corrective and Preventive Action Plan (CAPA) in Response to Global Risk Assessment (GRA) Audits;
  • Participate and Evaluate Site Quality Council Performance Data and Areas of Risk;
  • Share Inspection Best Practices and Knowledge in the CMSO segment;
  • Foster and support a collaborative Quality Culture at the sites;
  • Foster and Promote Communication, Harmonization, and Support across Technology Segments.

Your profile

  • Bachelor's Degree - medical engineering, medical technology, chemistry, microbiology, pharmacy, engineering, or related science-based degree;
  • Master's Degree preferred - in science, business, healthcare, or an equivalent combination of education and experience related to medical technology and Quality;
  • Assurance/Quality Control - advantage at large and complex sites;
  • Professional certifications are a must when required legally;
  • Practical Knowledge and Experience of Combination Product and/or Medical Device expert/SME;
  • Experience - 15 years of experience as a functional leader with technical, team management, and operational responsibility;
  • Continuous professional development;
  • Advanced hands-on practical knowledge in medical technology/engineering and Combination Product/Medical Device manufacturing;
  • Advanced knowledge of Combination Product/Medical Device-related current and upcoming legislation and industry best practices;
  • Advanced practical knowledge of pharmaceuticals manufacturing and control, facility design, utilities, maintenance, and calibration.

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© EuroJobsites 2021

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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