Senior Regulatory Science Specialist - Sterility & Transfer

Judge Group, Inc.; Mahwah (NJ); Vor Ort; USD 62.000 - 66.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Contract position

Zusammenfassung

The Judge Group, Inc. is seeking a Senior Specialist, Regulatory Science in Mahwah, NJ for a 12-month contract.

This role provides primary technical support for a product transfer project involving orthopedic medical devices, with responsibility for the ongoing monitoring program and regulatory compliance. You will partner with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to ensure product transfer meets microbiological, sterilization, and regulatory

Qualifikationen

• Knowledge of cGMP requirements and regulatory expectations.
• Experience with USP- and ISO-based testing methods.
• Experience authoring/testing documentation and final reports.

Aufgaben

• Support sterilization process validations and microbiological assessments for product transfer.
• Author, review and approve validation documentation and reports.
• Coordinate activities with cross-functional partners, labs, sterilizers and suppliers.

Kenntnisse

cGMP knowledge

Microbiology

Regulatory science

Documentation

Cross-functional collaboration

Analytical skills

Ausbildung

Bachelor’s in Biology

Bachelor’s in Microbiology

Biomedical Engineering

Toxicology

Tools

Sterilization validation

Environmental monitoring

ISO testing methods

Jobbeschreibung

The Judge Group, Inc. is seeking a Senior Specialist, Regulatory Science in Mahwah, NJ for a 12-month contract.

This role provides primary technical support for a product transfer project involving orthopedic medical devices, with responsibility for the ongoing monitoring program and regulatory compliance. You will partner with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to ensure product transfer meets microbiological, sterilization, and regulatory