Biocompatibility Specialist
Company: Highlander Consultants
Location: Jacksonville
Posted on: June 24, 2022
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Job Description:
Biocompatibility SpecialistJob Summary:Responsible for
evaluating the biocompatibility requirements for new products to
support regulatory submissions to US and Canadian Regulatory
Authorities. Responsible for assisting with submissions for
regulatory approvals, acts to identify and resolve regulatory
problems. Exercises discretion and independent judgement related,
but not limited to, domestic and international regulatory
submissions and interfacing with regulatory authorities on the
submissions.Duties & Responsibilities:--- Execution of biological
safety evaluations of medical devices according to ISO 10993,
including gap assessment activities--- Work to review existing
product documentation with respect to Biocompatibility,
Manufacturing Processes, Sterilization, Packaging and/or Cleaning
Validation information--- Understand and identify possible gaps for
ISO 10993-1 and supporting ISO 10993 testing where needed---
Compile/write/review Biocompatibility Test Plan, Test Report and
Risk Assessment of medical devices in accordance with regulatory
requirements (ISO, FDA, GLP)--- Develop Toxicology/Biocompatibility
Risk Assessment Strategies and write the Toxicological Risk
Assessment report in collaboration with other team members---
Collaborate with associates of diverse technical backgrounds and
partners with Regulatory Affairs, Quality Engineering,
Manufacturing, Packaging and Project Teams, to achieve desired
project outcomes--- Coordinator for outsourced studies---
Prioritize tasks according to broad project goals--- Researches
regulatory issues and contributes to regulatory team to provide
supervision, guidance, and advice to cross functional team
members--- Continually review the scientific literature to keep
current with new technical information--- Act as a trainer and
training content developer within the department--- Reviews design
and development documentation, including design history files, for
regulatory compliance with respect to biological evaluations---
Research requirements and provides options for regulatory
submissions, approval pathways, and compliance activities with
respect to biocompatibility testing--- Assesses product change
requests for impact on biocompatibility impact--- Builds strategic
partnerships to further departmental and organizational
objectives--- Maintains positive and cooperative communications and
collaborations--- Performs other related duties and
responsibilities, on occasion, as assignedEducation &
Experience:--- Minimum educational requirement is a BS degree in
relevant scientific disciplines, such as material science,
toxicology, chemistry, biology or similar; Master of Science
preferred although comparable areas of study and industry
experience is considered for the position--- 2-4 years experience
in the Medical Device Industry--- Experience in Biocompatibility
and familiarity with application of ISO 10993-1--- Experience with
FDA Interactions--- Previous experience leading projects and
presenting recommendations based on technical inputs from multiple
and varied functionsAdditional Skills / Abilities needed:---
Maintains high integrity and confidentiality of company and
department information--- Ability to work effectively with all
levels of internal and external associates, customers, and
colleagues--- Excellent interpersonal skills with the ability to
effectively communicate at all levels internally as well as
externally--- Ability to follow through on issues, make informed
decisions that comply with policies and procedures, complete tasks
and problem-solve--- Ability to work with minimal supervision---
Ability to manage multiple priorities--- Ability to organize and
track multiple projects in a detail-oriented and self-directed
manner--- Ability to work both independently and within a team
environment--- Possess intermediate to advanced level knowledge of
Microsoft OfficeThis can be a remote job in Jacksonville... the
candidate will have to visit the design/manufacturing plant /
office once a month.
Keywords: Highlander Consultants, Jacksonville , Biocompatibility Specialist, Other , Jacksonville, Florida
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