Clinical and Scientific - Medical Safety Writer II

Company: TalentBurst, Inc.
Location: Fort Worth
Posted on: January 27, 2023

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