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)
