Biocompatibility Specialist

Company: Highlander Consultants
Location: Jacksonville
Posted on: June 24, 2022

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