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Clinical Research Manager - Medical Device - ISO Audit

Company: Cameron Craig Group
Location: Schaumburg
Posted on: January 6, 2022

Job Description:


Clinical Research Manager - Medical Device - Technical Writing/ISO/Audit

A privately held, family-owned company whose core values are based on respect, positivity and team playing is seeking a dynamic professional with a background in research and technical writing for the medical device industry. If you are tired of feeling like a number in a big corporate environment and prefer a culture focused on collaboration and friendliness, this could be the right fit for you! This growing and innovative company has global recognition for their adhesives and composites used in the medical and dental industry. In addition to a great work environment, they offer top-notch benefits, a competitive salary and a structure that promotes a well defined work-life balance.
This position is based from a manufacturing and research facility in the Northwest Chicago suburbs, there is not a remote option at this time. The ideal candidate has either management or mentoring experience with a strong background in ISO audits, EU regulatory and technical writing for the medical device industry.

Requirements:


  • Bachelor's degree required. Advanced degree preferred. Degree in science, medicine, dentistry, or similar discipline highly preferred.
  • Technical writing: 5+ years with bachelor's degree, 5+ years with master's degree, 2+ years with doctoral degree.
  • EU regulatory document writings.
  • Project coordination experience.
  • Proficient in MS Office and general computer skills.
  • Strong organizational skills, multi-tasking, and self-motivation.
  • Strong verbal and written English communication skills.
  • Exceptional level of attention to detail.


    Duties and Responsibilities:

    • Leadership - Provide direction and oversight to direct reports, conduct performance management activities, and maintain positive working environment.
    • Principal Technical Writing / Research - Manage and provide writing of technical documentation including clinical evaluation reports, post-market surveillance reports, post-market clinical follow-up reports, periodic safety update reports, and summaries of safety and clinical performance.
    • Primary User / Product Research - Oversee primary user / product research including clinical research (verification, validation, usability, and PMCGCE) and non-clinical research for product planning and strategy.
    • Risk Management - Manage the risk management process, including contributions to PDs in design control, lead risk management task force.
    • Biocompatibility - Oversee the update and maintenance of biocompatibility evaluations for existing products and ensure they comply with current standards and regulations.
    • General - Support design control, work with Clinical Affairs and Regulatory Affairs, provide writing, editorial, and regulatory support to Marketing.



      Interested candidates must be legally authorized to work in the United States. Future Visa sponsorship is not available.

Keywords: Cameron Craig Group, Schaumburg , Clinical Research Manager - Medical Device - ISO Audit, Executive , Schaumburg, Illinois

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