Biocompatibility Specialist

Troy - Michigan - United States - Life Sciences & Health Care - Medical devices - Clinical - Professional Bachelor

Biocompatibility Specialist (Trauma, CMF and Spine)
Location: West Chester PA
Length: 1 year + open ended

Feel free to contact

Arpita Sharma, Account manager

Apply now

About you

Requirements:

  • 5 + years experience in Medical Device or pharma experience;
  • Medical device knowledge a must;
  • Thorough understanding of MDR regulations, ISO 10993 standards, and;
  • Understanding of Biochemistry, Analytical Chemistry, Manufacturing and how it is used within Medical Device.

What we offer

The Scope of Work includes; but is not limited to:
  • Work with site staff to locate and review existing Technical File/Design Dossier/ Design History File documentation and the supporting Product, Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or Cleaning Validation information for MDR transformation;
  • Understand and identify possible gaps for ISO 10993-1 and supporting ISO 1993 testing where needed;
  • Familiar with writing Biocompatibility Protocols and Reports;
  • Provide input to gap assessment tools that may be needed for project;
  • Develop Toxicology/Biocompatibility Risk Assessment Strategies and write the Toxicological Risk Assessment report in collaboration with other team members in support of a variety of projects of diverse scope. Participate in project teams as required. Toxicologist will review the Biocompatibility (Toxicology) sections of the technical files for a number of products and product families, to identify and remediate any deficiencies, and generate biocompatibility risk assessments for each of the technical files;
  • Function as Study Coordinator for outsourced studies;
  • Participate in the design and execution of preclinical efficacy and safety studies used to assess the biocompatibility and safety of medical devices, drugs, and combination products such as sutures, meshes and hemostats in accordance with regulatory requirements (ISO, ICH, GLP,);
  • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, ICH, FDA, etc) and compliance requirements (GLP, departmental SOP's, company policies, etc). Interpret regulations, implement compliance strategies to support the sale of new and existing products, as well as implement procedures in anticipation of regulatory activities;
  • Working under minimal supervision, conduct research and contribute to the origination and direction of experiments and new methodologies. Prioritize tasks according to broad project goals. Provide technical consultation on the implementation of experimental activities;
  • Comply with Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58);
  • Collaborate with associates of diverse technical backgrounds (chemistry, physiology, materials science, engineering, supplier quality, manufacturing) to achieve desired project outcomes.

Summary

  • Vacancy number: PUB203870
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Medical devices
  • Education level: Professional Bachelor
  • Area of Expertise: Clinical
  • Closing date: Saturday, May 4, 2019
Apply now

Feel free to contact

AS

Arpita Sharma

Account manager Brunel Canada Toronto

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