ProClinical is advertising a brilliant opportunity for a Biocompatibility Specialist vacancy to be based in Philadelphia. This job will be with one of the largest workforce management solutions companies in the world, who specialise in multiple scientific and engineering sectors.
- Working 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.
- Understanding and identifying possible gaps for ISO 10993-1 and supporting ISO 1993 testing where needed.
- Providing input to gap assessment tools that may be needed for projects.
- Developing Toxicology/Biocompatibility Risk Assessment Strategies and writing the Toxicological Risk Assessment report in collaboration with other team members in support of a variety of projects of diverse scope; participating in project teams as required.
- Reviewing 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.
- Functioning as Study Coordinator for outsourced studies.
- Participating 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 haemostats in accordance with regulatory requirements (ISO, ICH, GLP).
- Maintaining 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 SOPs, company policies, etc.).
- Interpreting regulations, implementing compliance strategies to support the sale of new and existing products, and implementing procedures in anticipation of regulatory activities.
- Working under minimal supervision, conducting research and contributing to the origination and direction of experiments and new methodologies.
- Prioritising tasks according to broad project goals and providing technical consultation on the implementation of experimental activities.
- Complying with Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58).
- Collaborating with associates of diverse technical backgrounds (chemistry, physiology, materials science, engineering, supplier quality, manufacturing) to achieve desired project outcomes.
Skills and Requirements:
- At least five years of experience with Medical Devices or pharma experience.
- A thorough understanding of MDR regulations, such as ISO 10993 standards.
- A thorough understanding of Biochemistry, Analytical Chemistry, Manufacturing, and how they are used within the Medical Device field.
- Familiarity with writing Biocompatibility Protocols and Reports.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +267-477-4800 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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