Remote: Regulatory Tech Writer (235100)

Life Sciences & Technology
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Duration

  • 6 months

Job Description

  • Our Medical Device client is looking for a Senior Regulatory Technical Writer with significant writing experience. They are in the midst of filing submissions for FDA and EU and need a writer who is very punctual and coachable to provide insight into various Regulatory questions. This role will require the consultant to write pre-subs, review and update IFU’s, put together sections of De Novo, support submissions in Brazil (close to MDD submission), and handle different types of reg writing and documents that go into submissions. The client is dealing with unprofessional grammar and punctuation, so this consultant needs to be excellent with grammar, punctuation, and know the content within Regulatory submissions. The Ideal candidate will have experience with IFU’s, submissions (510’k), MDD, and De Novo.
  • ASQ Cert and RAPs Cert on resume will be prioritized.
  • Plus: American Medical Writers Association

Education

  • Experience over Education

 

Remote: Regulatory Tech Writer (235100)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
US Remote

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