Manager, Biocompatibility

OverviewMCRA, an IQVIA Business, is looking to hire a Manager, Biocompatibility to lead the development and execution of biocompatibility strategies for medical devices, including chemical characterization, biological risk assessments, and regulatory documentation for U.S. and international submissions. It involves cross-functional collaboration with toxicologists and testing labs to ensure compliance with global standards. The ideal candidate has a strong background in chemistry or a related field, with at least five years of relevant experience and excellent technical writing and project management skills.ResponsibilitiesDevelop and execute biocompatibility services for client companies, including, but not limited to:Design, review, and implementation of chemical characterization studies in collaboration with third-party testing laboratoriesTechnical advisement pertaining to chemistry and materials science (e.g., degradation, corrosion, complex chemistries within medical devices)Preparation of Biological Evaluation Plans (BEP) and Reports (BER)Authoring biocompatibility sections in US regulatory submissions (510(k), IDE, PMA, IND, BLA, and IND) and for international regulatory submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs))Development of biocompatibility evaluation strategies, analyses, and documentationDesign, review, and implementation of biocompatibility evaluations including biological testing and biological risk assessments (BRA)Collaboration with in-house and third-party toxicologists to develop toxicological risk assessmentsReview and oversee technical writing and regulatory submission development by junior team membersContribute to the development of technical and regulatory documentsParticipate in team and client meetingsStay current on global medical device regulatory requirements, including chemical characterization, biological testing, and toxicological risk assessmentAttend conferences and meetings as neededComplete other duties and projects as assignedQualificationsEducation: Bachelor’s degree in a scientific discipline (chemistry, biology, engineering, or a heavily technical writing-based curriculum); Master of Science, Master of Science in Engineering, or PhD preferredChemistry degree (Bachelor’s, Master of Science, Master of Science in Engineering, PhD) preferredExperience: Minimum five years of experience in chemical characterization, biocompatibility science, and/or toxicology related to medical devices; writing and/or reviewing biocompatibility documentation. Post-graduate education with strong research and technical writing curriculum may be substituted for experienceExperience communicating scientific information with regulatory professionals; experience with global regulators preferredExperience reviewing, interpreting, and modifying chemical characterization testing protocolsExperience with chemical characterization analytical methods (e.g., GC-MS, LC-MS, ICP-MS, chemical identification) preferred; experience with ISO 13485 and ISO 14971 is preferredExperience with sterilization validation, packaging validation, and other medical device nonclinical testing is a plusExperience working with EU-MDR regulatory documentation preferredPost-graduate education with strong research and technical writing curriculum may be substituted for experienceTraining on biocompatibility/biological safety, and/or ISO 10993-1 will also be consideredOther SkillsStrong attention to detail and ability to work independently and within a multi-disciplinary team, as well as with external partners and vendorsExcellent critical thinking and project management skills for managing numerous, dynamic projects requiring prioritizationStrong written and verbal communication and presentation skillsUnderstanding of chemistry and materials science disciplines applicable to medical device evaluationUnderstanding of absorption and degradation of medical device materials in vitro and in vivoUnderstanding of biocompatibility science and data analysisAbility to implement analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirementsAbility to develop biological evaluation strategies and effectively communicate them to internal team members and clientsStrong research, analytical, critical-thinking and problem-solving skillsExcellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlinesAbility to lead and direct junior team members is a plusProfessional experience working with internal and client relationships at all levelsIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $84,900.00 - $212,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.LocationWashington, DC #J-18808-Ljbffr

Created: 2025-09-24