Regulatory Science Senior Specialist

Comrise; Mahwah (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Comrise is seeking a Regulatory Science Senior Specialist to provide technical support for orthopedic medical device transfer projects, collaborating with labs, sterilizers, and suppliers to ensure compliance and lifecycle sustainment.

The role requires knowledge of cGMP, USP/ISO testing, and regulatory expectations, with hands-on validation and documentation experience. This position follows standard business hours and involves cross-functional teamwork.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related field.
• 2–4 years in a medical device, pharmaceutical, or biotechnology environment supporting microbiology, sterilization, or sterility assurance activities.
• Experience authoring and reviewing technical documentation, including test plans, protocols, validation documentation, and final reports.
• Hands-on experience with terminal sterilization technologies, sterilization validation, microbiological testing, and biological testing strategies.
• Strong working knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, and Good Documentation Practices.
• Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Ability to manage multiple assignments, meet project deadlines, and work independently with minimal supervision.

Responsibilities

• Support sterilization process validations and microbiological assessments associated with 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, effectively communicating 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.
• Perform analysis, review, and trending of environmental monitoring data.
• Support investigations into out-of-specification (OOS) and nonconforming results within assigned areas.
• Operate and maintain laboratory equipment, complete preventive maintenance, and troubleshoot minor equipment issues.
• Maintain complete and accurate records in accordance with Good Documentation Practices (GDP) and established procedures.

Skills

cGMP knowledge

Microbiology techniques

Technical documentation

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Biology/ Microbiology/ Biomedical Engineering

Job description

Schedule: Monday – Friday, Standard Business Hours (8:00 AM – 4:00 PM or 9:00 AM – 5:00 PM)

Position Overview

We are seeking a Regulatory Science Senior Specialist to provide technical support for a high-priority product transfer project involving orthopedic medical devices, with secondary responsibilities supporting ongoing process monitoring programs. This role partners with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to ensure product transfer and lifecycle sustainment activities meet all applicable microbiological, sterilization, and regulatory standards.

The ideal candidate possesses practical knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, and medical device regulatory expectations, executing validation and technical documentation with minimal supervision.

Key Responsibilities

• Support sterilization process validations and microbiological assessments associated with 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, effectively communicating 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.
• Perform analysis, review, and trending of environmental monitoring data.
• Support investigations into out-of-specification (OOS) and nonconforming results within assigned areas.
• Operate and maintain laboratory equipment, complete preventive maintenance, and troubleshoot minor equipment issues.
• Maintain complete and accurate records in accordance with Good Documentation Practices (GDP) and established procedures.

Required Qualifications

• Bachelor’s degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline.
• 2 to 4 years of experience in a medical device, pharmaceutical, or biotechnology environment supporting microbiology, sterilization, or sterility assurance activities.
• Demonstrated experience authoring and reviewing technical documentation, including test plans, protocols, validation documentation, and final reports.
• Hands‑on experience with terminal sterilization technologies, sterilization validation, microbiological testing, and biological testing strategies.
• Strong working knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, and Good Documentation Practices.
• Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Ability to manage multiple assignments, meet project deadlines, and work independently with minimal supervision.

Preferred Qualifications

• Working knowledge of medical device standards and regulations, specifically ISO 11135 (EtO), ISO 11137 (Gamma), AAMI guidance, FDA requirements, and EU MDR.
• Direct experience supporting product transfers, manufacturing site transfers, or sterilization process changes for medical devices.
• Experience collaborating with external testing laboratories and contract sterilizers.
• Experience with environmental/water monitoring programs, data trending, and OOS investigations.