Senior Regulatory Scientist—Medical Devices

System One, Inc.; Mahwah (NJ); On-site; USD 55,000 - 78,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) plan

Job summary

System One, Inc. seeks a Regulatory Science Senior Specialist in Mahwah, NJ, on a contract basis, to support product transfer for orthopedic devices and ongoing process monitoring with cross-functional teams and external labs.

The role focuses on microbiology, sterilization validation, and regulatory compliance, with responsibilities including documentation, testing, and environmental monitoring in a regulated setting.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related field.
• 2–4 years in a regulated healthcare environment supporting microbiology, sterilization, or sterility activities.
• Experience authoring and reviewing technical documentation (test plans, protocols, reports).
• Experience with terminal sterilization technologies and sterilization validation.
• Working knowledge of cGMP, USP/ISO testing methods, and Good Documentation Practices.
• Strong written and verbal communication and cross-functional collaboration.
• Ability to manage multiple assignments and meet deadlines with minimal supervision.

Responsibilities

• Support sterilization process validations and microbiological assessments related to product transfer and lifecycle sustainment.
• Author, review, and approve protocols, validation docs, technical assessments, and final reports.
• Coordinate activities with cross-functional partners and external labs; clearly communicate requirements, results, risks, and status.
• Support environmental monitoring by conducting microbiological testing per procedures and regulatory requirements.
• Analyze, review, and trend environmental monitoring data.
• Assist investigations of out-of-specification results in assigned areas.
• Operate and maintain laboratory equipment; perform preventive maintenance and troubleshoot minor issues.
• Maintain complete records of work and document results per Good Documentation Practices.

Skills

Regulatory science

Microbiology

Sterilization knowledge

Technical writing

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Biology / Microbiology / Biomedical Engineering / Toxicology

Job description

System One, Inc. seeks a Regulatory Science Senior Specialist in Mahwah, NJ, on a contract basis, to support product transfer for orthopedic devices and ongoing process monitoring with cross-functional teams and external labs.

The role focuses on microbiology, sterilization validation, and regulatory compliance, with responsibilities including documentation, testing, and environmental monitoring in a regulated setting.