Clinical Regulatory Specialist - 29720BR - EN in Waardenburg at Stryker Corporation

Date Posted: 5/7/2018

Job Snapshot

Job Description

The Clinical Regulatory Specialist will I ideally work from the Regional Head Quarters based in the Netherlands or elsewhere within Eruope. But has a Global responsibility and will report to the US based manager. In the role you cover the full European Stryker area.

The Clinical Regulatory Specialist will take care of:
  • Prepare and analyze clinical data, journal articles and scientific presentations for surgeons and Company personnel and to support regulatory submissions.
  • Design, develop and write clinical plans and study protocols
  • Participate in product development teams
  • Support Regulatory Affairs in submission of IDEs, pre-market approval applications, amendments, supplements, and other regulatory submissions with regard to clinical issues
  • Perform Investigator qualification process and occasionally perform Investigator qualification visits
  • Initiate investigator agreements with Investigators
  • Facilitate Institutional Review Board (IRB) submissions and renewals
  • Lead and monitor device accountability process
  • Train study site personnel in study-related procedures
  • Prepare monitoring plan, review and follow up on monitoring visit reports
  • Conduct risk analysis and monitor reported adverse events
  • Serve as primary contact between study site personnel and sponsor regarding study-related issues
  • Develop and track study budgets
  • Collaborate with Data Management and Clinical IT groups on CRF design, final CRF approval, study set-up of databases, edit checks, User Acceptance Test, data entry Quality Control (QC), data review, and SAS reports
  • Continually monitor study site compliance with protocol and metrics and implement corrective actions
  • Lead data review process, review radiographic data, and participates in X-ray reviews
  • Prepare annual study progress reports and final reports, to include clinical and radiographic data, for FDA, Investigators and IRBs
  • Other relevant duties as assigned by management

Job Requirements

  • 5+ years of experience as a Clinical Research Associate, Clinical Project Manager or equivalent external position
  • Experience in the medical device field preferred; experience in the pharmaceutical industry considered
  • Demonstrated clinical regulatory experience including knowledge of the regulations, preparation of clinical sections of regulatory documents for FDA and international agencies.
  • Demonstrated ability to expand application of clinical and regulatory knowledge to interdivisional projects as needed
  • Applied knowledge of project management tools
  • Demonstrated interpersonal, written and oral communication skills
  • Demonstrated organization and planning skills
  • Demonstrated success in a team-based environment preferred
  • Demonstrated knowledge and application of personal computer systems and desktop applications

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