Manager, Biocompatibility

MCRA, an IQVIA Business MCRA, 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. This role 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. Responsibilities Develop 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 laboratories Technical 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, & IND) and authoring biocompatibility sections for international regulatory submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs)) Development of biocompatibility evaluation strategies, analyses & documentation Design, 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 assessments Review and oversee technical writing and regulatory submission development by junior team members Contribute to the development of technical and regulatory documents Participate in team and client meetings Stay current on global medical device regulatory requirements, including chemical characterization, biological testing, and toxicological risk assessment Attend conferences and meetings as needed Complete other duties and projects as assigned Required Skills, Education, and Qualifications Education: 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 preferred. Experience: 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 experience. Experience communicating scientific information with regulatory professionals; communication experience with global regulators preferred. Experience reviewing, interpreting, and modifying chemical characterization testing protocols. Experience with chemical characterization analytical methods (e.g., GC-MS, LC-MS, ICP-MS, chemical identification) preferred. Experience with quality management systems (ISO 13485), risk assessment (ISO 14971) preferred. Experience with sterilization validation, packaging validation, and other medical device nonclinical testing is a plus. Experience working with EU-MDR regulatory documentation preferred. Post-graduate education with strong research and technical writing curriculum may be substituted for experience. Training on biocompatibility/biological safety, and/or ISO 10993-1 will also be considered. Other Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors Excellent critical thinking and project management skills for managing numerous, dynamic projects requiring prioritization Strong written and verbal communication and presentation skills Understanding of chemistry and materials science disciplines applicable to medical device evaluation Understanding of absorption and degradation of medical device materials in vitro and in vivo Understanding of biocompatibility science and data analysis Understanding and experience in implementing analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirements Understanding of disciplines related to medical device biocompatibility to develop biological evaluation strategies and communicate them effectively Strong research, analytical, critical-thinking and problem-solving skills Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently Ability to lead and direct junior team members is a plus Strong professionalism and experience working with internal and client relationships at all levels IQVIA 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 IQVIA jobs. IQVIA 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. Learn more at IQVIA jobs/eoe. The 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. #J-18808-Ljbffr

Created: 2025-09-23