Regulatory Science Senior Specialist

This role will partner with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to ensure that product transfer and lifecycle sustainment activities meet applicable microbiological, sterilization, and regulatory requirements. 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.

Job Title: Regulatory Science Senior Specialist
Location: Mahwah, NJ
Hours: 8:00am to 5:00pm
Type: Contract

Overview
The role will provide primary technical support for a product transfer project involving orthopedic medical devices, with secondary responsibility for the ongoing process monitoring program. This role will partner with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to ensure that product transfer and lifecycle sustainment activities meet applicable microbiological, sterilization, and regulatory requirements.
The position requires practical knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, safety procedures, and medical device regulatory expectations. The individual will apply sound technical judgment to validation, testing, data review, investigations, and technical documentation while managing assignments with minimal supervision.


Responsibilities

• Support sterilization process validations and microbiological assessments associated with product transfer, manufacturing changes, and product lifecycle sustainment.
• Author, review, and approve protocols, validation documentation, technical assessments, and/or final reports evaluating compliance with applicable microbiological and sterilization requirements.
• Coordinate technical activities with cross-functional partners, external testing laboratories, contract sterilizers, and suppliers; communicate requirements, results, risks, and project status clearly.
• Support the ongoing environmental monitoring program by conducting or coordinating microbiological testing in accordance with approved procedures and regulatory requirements.
• Perform and support the analysis, review, and trending of 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 and document results in accordance with Good Documentation Practices and established procedures.

Requirements

• Bachelor’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 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.

• Working 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 that support microbiological, biological safety, or sterilization activities.
• Experience with environmental or water monitoring programs, data trending, and investigation of out-of-specification results.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific