Clinical and Scientific - Medical Safety Writer II
Company: TalentBurst, Inc.
Location: Fort Worth
Posted on: January 27, 2023
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Job Description:
Job Title: Medical Safety Writer II- Toxicology
Location: Fort Worth TX
Duration: 6+ months
Job Description: Currently in need of an experienced Toxicologist
to assist with EU MDR initiative. This contractor will have
hands-on experience in Toxicology and should have experience with
Biologics Evaluation Reports (BERs) and should have a strong
understanding of the new EU MDR requirements, specific to
non-clinical biocompatibility.
Duties:
" Partner with toxicologists to develop robust biocompatibility and
nonclinical documentation to meet project goals and ensure patient
safety of products.
" Conduct safety assessment for new product development and provide
solutions for evaluation of safety risk for manufacturing and
product life cycle assessments.
" Interpret data and develop justifications to address
biocompatibility in alignment with ISO 10993-1
" Support of gap assessment related to European Union Medical
Device Regulation (MDR).
" Familiar or experience with medical device submissions (e.g.,
PMA, IDE, MDR, etc.) to regulatory authorities.
" Biocompatibility and toxicology expertise in ophthalmic medical
devices.
" Proficient in Microsoft Office.
" Ability to work independently and meet targeted timelines.
" Good written and verbal communication.
" Attention to detail, strategic thinking and problem solving
skills.
" Experience in preparing or contributing to regulatory reports/
submission involving safety information.
Key Requirements/Minimum Requirements
" Bachelor's Degree or equivalent years of directly related
experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0
yrs)
" The ability to fluently read, write, understand and communicate
in English
" 3 Years of Relevant Experience
#LI-FRESH
Keywords: TalentBurst, Inc., Fort Worth , Clinical and Scientific - Medical Safety Writer II, Healthcare , Fort Worth, Texas
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