Quality Assurance And Regulatory Affairs Specialist Position Available In Middlesex, New Jersey

Quality Assurance And Regulatory Affairs Specialist (part of Allegis Group) 3.5 3.5 out of 5 stars 145 BEVIER ROAD, Piscataway, NJ 08854

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Quality Assurance and Regulatory Affairs Specialist Job Description As a Quality Assurance and Regulatory Affairs Specialist, you will play a crucial role in supporting all activities related to Licensure and Accreditation. Your responsibilities will encompass preparing and supporting regulatory submissions at both state and federal levels. Additionally, you will be involved in tracking Quality Indicators, ensuring Inspection Readiness, managing Training Records, Competencies, and Proficiency Testing, and participating in audits and Audit Readiness Walkthroughs. Responsibilities Apply working knowledge of applicable regulations and standards (e.g., ISO, FDA, CAP, CLIA, GMP, GCP, GLP, ICH, and other global standards) to provide regulatory guidance and support the development of global regulatory strategies for a clinical laboratory. Prepare regulatory submission documents for the FDA or other regulatory agencies (e.g., 510(k), PMA, NY

DOH, NJ DOH

) by collaborating with project teams to implement design control, risk management, or other applicable principles into regulatory submission processes/documents. Maintain state and federal licenses and all applicable accreditations, ensuring licensures are current. Demonstrate a working knowledge of Good Documentation Practice, Good Clinical Practice, and Good Laboratory Practice. Demonstrate a working knowledge of design change control. Support and participate in audits and inspections by sponsors, regulatory authorities, and clients. Support Quality Management System (QMS) processes. Coordinate communication methods (meetings, presentations, documentation) to drive the timely closure of issues. Lead monthly meetings related to compliance and Clinical compliance, maintain and distribute meeting minutes. Develop and maintain mechanisms to track and trend regulatory compliance. Develop and monitor Laboratory Key Performance Indicators (KPIs). Ensure that all Quality Indicators are being monitored, training records/competencies are current, and Proficiency Testing is implemented on time. Confirm that lab managers maintain all Equipment logbooks, maintenance, and validation activities. Drive completion of internal audits in accordance with the audit schedule. Be an effective team player, demonstrating behaviors reflecting company values: delighting clients, moving innovation forward, accelerating business, rising together as a team, and transcending what is possible. Support Regulatory Affairs and Quality Assurance management as needed. Perform all other duties as assigned. Essential Skills Bachelor’s degree in chemistry, scientific, or engineering discipline (or longer relevant experience with a different degree discipline). 4+ years of work experience in quality assurance and/or regulatory affairs in the medical device, biotech, life sciences, or pharmaceutical industry. Expertise and knowledge of clinical assays and/or medical devices in a regulated environment. Working knowledge of applicable regulations and standards (e.g., ISO, FDA, CAP, CLIA, GMP, GCP, GLP, ICH, and other global standards) to provide regulatory guidance. Excellent knowledge and experience with global US and outside US regulatory requirements. Ability to identify, research, analyze technical documentation, and interpret governmental regulations. Excellent verbal and written communication skills. Effective interpersonal and cross-functional collaboration skills. Experience serving as a regulatory liaison (interpreting regulations) and working in cross-functional teams. Capable of handling multiple tasks/projects and managing priorities accordingly. Thrives under pressure in a dynamic, timeline-driven environment. Self-motivated and capable of working independently with minimal management oversight. Excellent root cause analysis, problem-solving, and analytical skills, including Corrective and Preventive Actions (CAPAs). Experience in participating in and/or hosting regulatory and client audits. Additional Skills & Qualifications Laboratory Developed Tests experience advantageous. Work Environment The position is based in a biorepository with a standard work schedule from Monday to Friday, 8:00 AM to 4:30 PM. The role does not require weekend work, except in special instances if available, and there is no travel involved. The position is 100% onsite. Pay and Benefits The pay range for this position is $28.00 – $31.25/hr. 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) Workplace Type This is a fully onsite position in Piscataway,NJ. Application Deadline This position is anticipated to close on Jun 25, 2025. 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.