Senior Regulatory Science Specialist

Actalent; Mahwah (NJ); On-site; USD 55,000 - 78,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability

Paid Time Off

Job summary

Actalent is seeking a Senior Specialist, Regulatory Science (Medical Device Sterilization & Microbiology) to provide technical support for product transfer projects and ongoing regulatory-compliant environmental monitoring in a regulated medical device environment.

The role emphasizes hands-on sterilization validation, microbiological testing, documentation, and cross-functional collaboration with external labs and suppliers.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related scientific discipline.
• 2–4+ years in regulated healthcare environment (medical device, pharma, biotech).
• Experience supporting microbiology, sterilization, sterility assurance, or environmental monitoring.
• Hands-on experience with sterilization validation and terminal sterilization technologies.
• Experience authoring validation protocols, technical assessments, and reports.
• Working knowledge of cGMP, USP/ISO standards, GDP, lab methods, and safety.

Responsibilities

• Support sterilization validations and microbiological assessments related to product transfers, manufacturing changes, and lifecycle sustainment activities.
• Author, review, and approve validation protocols, technical assessments, test plans, and final reports.
• Partner with cross-functional teams, external laboratories, contract sterilizers, and suppliers to coordinate technical activities and communicate risks, results, and project status.
• Support environmental monitoring programs by performing or coordinating microbiological testing in accordance with approved procedures and regulatory requirements.
• Analyze, trend, and review environmental monitoring data.
• Investigate out-of-specification (OOS), nonconforming, and deviation-related events.
• Operate, maintain, and troubleshoot laboratory equipment while ensuring preventive maintenance requirements are met.
• Maintain accurate documentation in accordance with cGMP and Good Documentation Practices (GDP).

Skills

Sterilization Validation

Sterility Assurance

Environmental Monitoring

Microbiological Testing

cGMP

USP Standards

ISO Standards

Protocol & Report Authoring

Regulatory Compliance

Education

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

Job description

Senior Specialist, Regulatory Science (Medical Device Sterilization & Microbiology)

Position Overview

This role will provide technical support for product transfer projects involving orthopedic medical devices, while also supporting ongoing environmental monitoring and process monitoring programs. The individual will collaborate with cross-functional teams, external laboratories, contract sterilization vendors, and suppliers to ensure compliance with microbiological, sterilization, and regulatory requirements.

The ideal candidate will have hands-on experience in sterilization validation, microbiological testing, environmental monitoring, technical documentation, and regulatory compliance within a medical device or other highly regulated environment.

Key Responsibilities

• Support sterilization validations and microbiological assessments related to product transfers, manufacturing changes, and lifecycle sustainment activities.

• Author, review, and approve validation protocols, technical assessments, test plans, and final reports.

• Partner with cross-functional teams, external laboratories, contract sterilizers, and suppliers to coordinate technical activities and communicate risks, results, and project status.

• Support environmental monitoring programs by performing or coordinating microbiological testing in accordance with approved procedures and regulatory requirements.

• Analyze, trend, and review environmental monitoring data.

• Investigate out-of-specification (OOS), nonconforming, and deviation-related events.

• Operate, maintain, and troubleshoot laboratory equipment while ensuring preventive maintenance requirements are met.

• Maintain accurate documentation in accordance with cGMP and Good Documentation Practices (GDP).

Required Qualifications

• Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline.

• 2-4+ years of experience in a medical device, pharmaceutical, biotechnology, or other regulated healthcare environment.

• Experience supporting microbiology, sterilization, sterility assurance, or environmental monitoring programs.

• Hands-on experience with sterilization validation, terminal sterilization technologies, microbiological testing, and biological testing strategies.

• Experience authoring and reviewing protocols, validation reports, technical assessments, and other controlled documents.

• Working knowledge of:

• cGMP requirements

• USP and ISO testing standards

• Good Documentation Practices (GDP)

• Laboratory methods and safety procedures

• Strong communication skills with the ability to work cross-functionally and manage multiple priorities with minimal supervision.

Preferred Qualifications

• Experience within the medical device industry, particularly sterile and orthopedic products.

• Knowledge of:

• ISO 11135 (Ethylene Oxide Sterilization)

• ISO 11137 (Radiation Sterilization)

• AAMI standards

• FDA regulations

• EU MDR requirements

• Experience supporting product transfers, site transfers, or sterilization process changes.

• Experience working with contract sterilizers, external testing laboratories, and suppliers.

• Experience with environmental monitoring, water monitoring, data trending, and OOS investigations.

Top Skills

• ISO 11135

• ISO 11137

• Sterilization Validation

• Sterility Assurance

• Environmental Monitoring

• Microbiological Testing

• Medical Device Regulations

• cGMP

• USP Standards

• Protocol & Report Authoring

Experience Level: Senior / Mid-Level (2-6+ years of relevant industry experience)

Job Type & Location

This is a Contract position based out of Mahwah, NJ.

Pay and Benefits

The pay range for this position is $48.00 - $48.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Mahwah, NJ.

Application Deadline

This position is anticipated to close on Nov 12, 2026.

Workplace Type

This is a fully onsite position in Mahwah,NJ.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.