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Clin Eval Med Writer - Exempt

Company

LanceSoft Inc

Location

Lafayette, Colorado, United States

Type

Full-time

We are seeking a highly skilled professional to join our team as a Clinical Evaluation Medical Writer. This role offers an exciting opportunity to work in a dynamic environment where you will contribute to the development and implementation of clinical evaluation documents in compliance with the European Union Medical Device Regulation (EU MDR). Join us in Lafayette, CO, a vibrant location that offers a great quality of life with its beautiful landscapes and community-focused atmosphere.



Must Have:


  • Advanced proficiency in Microsoft Word, including structured formatting, templates, track changes, and document control.

  • In-depth understanding of EU MDR safety and performance requirements.

  • Expertise in literature analysis for PSUR and client documents.

  • Experience as a PSUR Medical Writer.

  • Knowledge of Post Market Clinical Follow Up (PMCF) and Periodic Safety Update Report (PSUR) writing in compliance with...

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