Scientist

Ascent Services Group
Published
October 3, 2020
Location
Jacksonville, FL
Category
Job Type

Description

Job Title: Hazardous Substance Specialist
Contract 1 Year
Location Jacksonville FL (Remote)

  • Prefer local candidates but would be open to remote candidates anywhere in the US if they were the perfect fit. Strong preference on local.

    Ear, Nose, & Throat (ENT) Team in Jacksonville, FL plays a vital role in the treatment of ENT conditions, such as otolaryngology disorders and head & neck cancer.
     

Responsibilities may include the following and other duties may be assigned:

  • Apply both technical knowledge and organizational skills to carry out hazardous substances compliance efforts for the ENTF business.
  • Will work under limited guidance of *** Hazardous Substance subject matter expert (SME).
  • Collect and document hazardous substances compliance information for all ENT products with priority towards products sold in the European Union, for example:
    • Hazardous Substances
    • Restriction of Hazardous Substances (RoHS) 3 (main emphasis)
    • European Union Medical Devices Regulation (EU MDR)
    • Proposition 65 (Prop 65)
       
  • REACH
    Materials of Concern:
    • Latex
    • Animal-Derived Material (ADM)
  • Act as SME on all pertinent regulations, standards, and laws pertaining to materials of concern/hazardous substances.
  • Collaborate with Research & Development (R&D) and Quality Assurance to develop expertise on material composition of all products.
  • Work with Supplier Quality Engineering (SQE) to assess materials of concern/hazardous substances present in raw materials, components, and finished goods for Original
  • Equipment Manufacturer (OEM) and Contract Manufacturer (CM) products.
  • In collaboration with SQE, coordinate lab testing on raw materials, components, and finished goods for OEM and CM products as necessary.
  • Document materials of concern/hazardous substances data.
  • Coordinate information to Labeling to ensure devices are properly labeled per all pertinent regulations, standards, and laws.
  • Support cross functional Regulatory Affairs activities with product submissions/geography inquiries regarding materials of concern/hazardous substances.
  • Assist R&D to define design requirements pertaining to materials of concern/hazardous substances.
  • Lead or support remediation efforts to ensure compliance to all pertinent regulations, standards, and laws. This may include prioritization and recommended design changes.
  • Work with Toxicologist SME and cross functional peers to create and/or obtain supportive risk assessment documentation (i.e., hazardous substances justifications).
  • Assist with basic biocompatibility work and remediation.

Minimum Requirements

 

  • Bachelors Degree in Science, Engineering, or technical field.
     

Nice to Have (Preferred Qualifications):

  • 2+ years work experience in applicable field
  • Masters degree
  • Degree in toxicology, chemistry, or materials science
  • Medical device experience or experience in a regulated environment
  • Direct experience with EU MDR requirements and laws for hazardous substances
  • Experience/knowledge working in a product lifecycle management system (e.g., Agile PLM)
  • Analytical chemistry experience
  • Excellent communication skills
  • Ability to work effectively within team and across functions

     

Apply
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