Job Title: Regulatory Specialist

Location: Mahwah, NJ

Type: Contract

Responsibilities

Author and execute protocols and final reports to assess impact of manufacturing related changes against cleanliness requirements for impacted medical devices. May provide analysis and evaluation of materials and products at all stages of development process.

Help manage the execution microbiological and chemistry testing both internally and externally.

Communicate and collaborate with project owners to obtain all necessary information for assessment. May entail communication with internal operations and/or external suppliers.

Conducts work in compliance with cGMP/cGDP, safety and regulatory requirements.

Requirements

Knowledge of medical devices, concepts of manufacturing equipment, and/or sterilization preferred.

Knowledge of cGMP/cGDP required.

Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision.

Must have effective verbal and written communication skills.

Efficient computer skills with basic knowledge of Microsoft Office. (i.e. Word/PowerPoint/Excel/Outlook/Teams)

B.S. degree in Biological Sciences or related field with minimum of 5 years of Quality Assurance and/or Sterility Assurance experience preferred.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.