Senior Specialist, Regulatory Science - Individual Contributor
Dexian · Ramsey, NJ
Tailor my CV for this job — freePosition SummarySenior Specialist, Regulatory Science - Individual ContributorProvide primary technical support for a product transfer project involving orthopedic medical devices, along with secondary responsibility for an ongoing process monitoring program. Partner with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to support product transfer and lifecycle sustainment activities that meet applicable microbiological, sterilization, and regulatory requirements.This role applies technical judgment to validation, testing, data review, investigations, and technical documentation. Success requires practical knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, safety procedures, and medical device regulatory expectations, as well as the ability to manage assignments with minimal supervision. Key ResponsibilitiesSupport sterilization process validations and microbiological assessments related to product transfers, manufacturing changes, and product lifecycle sustainment.Author, review, and approve protocols, validation documentation, technical assessments, and final reports evaluating compliance with applicable microbiological and sterilization requirements.Coordinate technical activities with cross-functional partners, external testing laboratories, contract sterilizers, and suppliers.Clearly communicate requirements, results, risks, and project status.Support the ongoing environmental monitoring program by conducting or coordinating microbiological testing in accordance with approved procedures and regulatory requirements.Analyze, review, and trend environmental monitoring data.Support investigations of out-of-specification and other nonconforming results within assigned areas.Operate and maintain laboratory equipment, complete required preventive maintenance, and troubleshoot minor equipment issues.Maintain complete and accurate records of work performed.Document results in accordance with Good Documentation Practices and established procedures.Required QualificationsBachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline.Two to four years of experience in a medical device, pharmaceutical, biotechnology, or other regulated healthcare environment supporting microbiology, sterilization, or sterility assurance activities for sterile products.Experience authoring and reviewing technical documentation, including test plans, protocols, validation documentation, technical assessments, and final reports.Experience with terminal sterilization technologies, sterilization validation, microbiological testing, and the development or application of biological testing strategies.Working knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, Good Documentation Practices, and applicable safety procedures.Effective written and verbal communication skills, including the ability to explain technical concepts clearly and collaborate with cross-functional teams.Demonstrated ability to manage multiple assignments, meet project commitments, and complete work accurately and compliantly with minimal supervision.Preferred QualificationsWorking knowledge of applicable medical device regulations and standards, including ISO 11135, ISO 11137, AAMI guidance, FDA requirements, EU MDR, and other relevant regulatory requirements.Experience supporting product transfers, manufacturing site transfers, or sterilization process changes for medical devices.Experience working with external testing laboratories, contract sterilizers, and suppliers supporting microbiological, biological safety, or sterilization activities.Experience with environmental or water monitoring programs, data trending, and investigations of out-of-specification results.Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support. Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.