CER Medical Writer

1 week ago


North Chicago, United States Rangam Full time

Regulatory Submission Writer

  • Ivd or medical device or pharma experience
  • Proofreading on the submission
  • author the submission is plus
  • Working with cross-functional team
  • Regulatory submission
  • Product labelling
  • Looking for regulatory background
  • Ivdr submission, Pma, 510k submission
  • Regulatory submission writing

Role Requirements and Expectations:

  • The company is seeking candidates for a position in regulatory submission writing, distinct from general medical or technical writing roles.
  • The main requirement is experience in regulatory submissions, specifically related to IVDR in the EU or FDA submissions in the US, such as PMA, BLA, or 510 submissions.
  • Candidates with experience limited to promotional, web-based content, e-learning materials, or job aids are not suitable for this role.
  • A background in editing or proofing regulatory submissions is acceptable, though the ability to write these documents is preferred.

Educational and Experience Preferences:

  • While a degree in life sciences is not required, relevant experience in regulatory writing is critical.
  • Applicants from diverse educational backgrounds, including journalism or English, are welcome, as long as they can effectively communicate complex information to the FDA.
  • The position demands a minimum of five years of industry experience in regulatory writing. This role is not intended for individuals with only academic exposure to regulatory affairs.

Operational Details:

  • The role is within the transfusion medicine organization, which deals with blood screening products. While specific product experience in blood screening isn't necessary due to its niche market, a background in in vitro diagnostics, medical devices, or pharmaceuticals is advantageous.
  • This is an on-site role based in Lake County, Chicago, with no option for hybrid or remote work. Although the job description mentions the possibility of up to 5% international travel, it is unlikely for contractors.


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