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)
Materials of Concern:
- 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.
- 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