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Senior Specialist Change Control in Limerick at Stryker Corporation

Date Posted: 3/8/2019

Job Snapshot

Job Description

  • Ireland / North America
    • Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required

       and

  • Minimum of 2 years’ experience in areas of  Quality Management Systems or equivalent area
  • Minimum of 5 years in Quality/Regulatory Affairs environment.
  • Experience working in a regulated environment required.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
  • Thorough knowledge and understanding of US and International Medical Device Regulations.
  • Strong knowledge of Quality Systems (e.​g.​ CA​PA, Audits, Management review, Quality Planning).
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
  • Strong interpersonal skills.
  • Strong written and oral communication and negotiations skills.
  • Strong in critical thinking and "outside the box" thinking.
  • Highly developed problem solving skills.
  • Strong analytical skills.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently.
  • Experience in working in a compliance risk situation.
  • Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages

Some travel may be required.​

Work From Home: No

Travel Percentage: None

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