IQVIA
Overview
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, 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, and IND) and for international regulatory submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs)) Development of biocompatibility evaluation strategies, analyses, and 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 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 biocompatibility documentation. Post-graduate education with strong research and technical writing curriculum may be substituted for experience Experience communicating scientific information with regulatory professionals; 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 ISO 13485 and ISO 14971 is 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 Skills
Strong attention to detail and ability to work independently and 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 Ability to implement analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirements Ability to develop biological evaluation strategies and effectively communicate them 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 Ability to lead and direct junior team members is a plus Professional 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 https://jobs.iqvia.com 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. https://jobs.iqvia.com/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. Location
Washington, DC
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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, 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, and IND) and for international regulatory submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs)) Development of biocompatibility evaluation strategies, analyses, and 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 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 biocompatibility documentation. Post-graduate education with strong research and technical writing curriculum may be substituted for experience Experience communicating scientific information with regulatory professionals; 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 ISO 13485 and ISO 14971 is 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 Skills
Strong attention to detail and ability to work independently and 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 Ability to implement analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirements Ability to develop biological evaluation strategies and effectively communicate them 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 Ability to lead and direct junior team members is a plus Professional 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 https://jobs.iqvia.com 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. https://jobs.iqvia.com/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. Location
Washington, DC
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