Manager, Biocompatibility

Manager, Biocompatibility page is loaded## Manager, Biocompatibilitylocations: Washington, DC, United States of Americatime type: Full timeposted on: Posted Todayjob requisition id: R1504573### **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. 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.### ### **Responsibilities:*** ### Develop and execute biocompatibility services for client companies, including however 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) o 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. + ### Chemistry degree (Bachelor’s, Master of Science, Master of Science in Engineering, PhD) preferred.* ### EXPERIENCE: + ### Minimum five years of experience in chemical characterization, biocompatibility science, and/or toxicology related to medical devices; writing and/or reviewing of 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. o 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. + ### Possesses excellent critical thinking and project management skills for managing numerous, dynamic projects requiring prioritization and pivoting when appropriate. + ### Possesses strong written and verbal communication and presentation skills. + ### Understanding of chemistry and materials science disciplines applicable to medical device evaluation, including but not limited to organic chemistry, polymer chemistry. + ### 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. + ### Possesses an understanding of disciplines related to medical device biocompatibility (e.g., biology, toxicology, engineering, and/or regulatory affairs) to develop biological evaluation strategies and is able to effectively communicate these strategies to internal team members and clients. + ### 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 atIQVIA 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.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.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. #J-18808-Ljbffr

Created: 2025-09-21