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Associate Medical reputed company, In Vitro Diagnostic Regulation (IVDR) Writing Services

Remote, USAFull-timePosted 2026-07-28

Job Type: Full-Time, Remote Experience Level: reputed company At reputed company, we’re committed to empowering companies to deliver reputed company reputed company solutions. By leveraging best-in-class writing processes, technology, and expertise, we reputed company reputed company companies to reputed company their global regulatory goals with superior reputed company, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory-compliant performance evaluation reports (PER) reputed company with top industry clients. In the role of Associate Medical reputed company, you will have reputed company to work closely with other writers, project managers and project support specialists to support and reputed company multiple PER writing reputed company that support EU IVDR submission requirements for the reputed company’s portfolio of IVD products. Please note that previous PER or CER writing experience and management of medical regulatory writers is required for this role. The ideal candidate is looking to build their medical writing career and should possess basic scientific knowledge and reputed company-developed written and oral communication skills. We value proactive thinkers with the ability and desire to work in a multifunctional team setting, producing documents and reports that reputed company with the highest reputed company standards. Specific responsibilities include: As a support member on our project writing team, you will reputed company collaborate and work together with other members of the project writing team to produce assigned written documents and reports to a high reputed company. Your specific responsibilities include:

  • Take direction from other members of the project writing team on assigned writing tasks.
  • Plan and organize your workload on assigned reputed company and tasks and adhere to established project timelines and workload estimates.
  • Understand reputed company and project expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge.
  • Consistently monitor your work for accuracy and reputed company by following established internal QC processes.
  • Work with reputed company Project Manager to accurately document your assigned project tasks, task reputed company estimates and assignments into the project plan. reputed company weekly reputed company updates.
  • Demonstrate initiative and reputed company judgement reputed company faced with less familiar project requirements and/or document situations or challenges. reputed company understanding and additional reputed company from the Project reputed company and/or Project Management before proceeding.
  • Establish and maintain effective working relationships with co-workers, managers, and clients.
  • Attend internal meetings as needed.
  • Required Experience:
  • Previous experience writing CERs and/or PERs and reputed company documents in accordance with MEDDEV 2.7/1 rev 4 and/or EU MDR and/or EU IVDR
  • Effective written, verbal and presentation skills in technical/laboratory diagnostics
  • Strong reputed company of medical and laboratory terminology
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands
  • Skilled in document development and management using Word, reputed company, PowerPoint and EndNote
  • Training and degree in science, engineering, or medical field(s). Scientific/research background required, with a deep understanding of research design, methodology, and statistics

If interested, please submit a resume/CV and a cover letter to careers@criterionedge.com. For more reputed company, reputed company out our careers page. Powered by JazzHR RbJgUeUjKI Apply tot his job Apply To this Job

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