Principal Biologist - Quality Labs

Expiring today

Employer
Edwards Lifesciences Corp
Location
Westchester, CA
Posted
Jul 21, 2021
Closes
Jul 24, 2021
Ref
2327984142
Organization Type
Corporate
* This position is eligible for full relocation OR can be remote-based in the US Quality Labs provide a comprehensive range of testing and consulting services for safety and biocompatibility evaluation of medical devices. The Principal Biologist will participate in the development and implementation of biological safety test strategies in compliance with ISO 10993, for submissions to FDA and other regulatory agencies. We are looking for an experienced scientist who enjoys being hands on, working in a fast-paced environment, and who can effectively lead biocompatibility safety evaluation strategy for a variety of medical devices. Key Responsibilities: * Collaborate with cross-functional teams to develop ISO 10993 Biological Safety Evaluation testing strategy for new and modified devices * Interface with engineers, project teams, regulatory teams and management to develop an understanding of the device, component, or any modifications to the device * Manage and execute multiple projects involving chemical, in vitro and in vivo studies in a fast paced environment * Collaborate and manage external vendors, including contract research organizations and cross functional teams to ensure R&D project timelines are met * Help to compile and review regulatory data packages to FDA/other relevant authorities * Serve as the technical lead in addressing biocompatibility questions from regulatory agencies and notified bodies Education and Minimum Requirements: Bachelor's degree in Biology or related field, and 10+ years of relevant experience working in a biocompatibility or biological safety function for the medical device industry or a combination of med device and another life science sector (pharma, biotech, CRO) OR Master's degree in Biology or a related field, and 8+ years of relevant experience working in a biocompatibility or biological safety function for the medical device industry or a combination of med device and another life science sector (pharma, biotech, CRO) OR PhD degree in Biology or a related field, and 6+ years of relevant experience working in a biocompatibility or biological safety function for the medical device industry or a combination of med device and another life science sector (pharma, biotech, CRO) Preferred Qualifications: * Biology or biocompatibility experience with implantable cardiovascular medical devices Additional Talents and General Expectations: * Extensive knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO 10993) required * Expert understanding of FDA and EU regulatory requirements for pharmaceutical and medical device industry * Experience with critical evaluation of toxicological studies (both in vitro and in vivo) * Experience in materials biocompatibility and toxicological assessments for medical devices preferred * Deep knowledge and expertise in medical devices, and capability to propose necessary testing to establish the safety/biocompatibility of medical devices and their compliance with regulatory agencies guidelines * Knowledge and expertise with latest practices in risk assessment and chemical characterization of extractables/leachables following ISO 10993 * Ability and desire to work effectively in a multidisciplinary team environment * Thorough working knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) * Excellent written and oral communication skills, including strong formal presentation and analytical skills * Excellent problem-solving, organizational, analytical and critical thinking skills * Knowledge and understanding of polymer chemistry/analytical chemistry principles, theories and concepts is a plus * Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment is a plus * High energy, and resourceful person who is capable of quickly taking control of his responsibilities, building capable strategies and establishing himself as a credible strategic partner * Ability to manage confidential information with discretion * Strict attention to detail * Ability to interact professionally with all organizational levels * Work very well with customer, and communicate main technical issues and progress of the projects Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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