Regulatory Auditor

MTF Biologics; Edison (NJ); Hybrid; USD 79,000; Full time

Job summary

An established industry player is seeking a Regulatory Auditor to ensure compliance with critical standards and regulations. This hybrid role involves planning and conducting audits, both internally and externally, while fostering partnerships with suppliers. The ideal candidate will possess a strong background in regulatory affairs, particularly within FDA-regulated industries, and demonstrate excellent communication and organizational skills. With a comprehensive benefits package and opportunities for professional growth, this position offers a rewarding career in a dynamic and supportive environment.

Benefits

4 weeks PTO

Paid Holidays

Comprehensive Health Insurance

401K with Match

Disability Insurance

Life Insurance

Tuition Reimbursement

Flexible Spending Accounts

Adoption Assistance

At-home Physical Therapy Services

Qualifications

• 3+ years of experience in quality or regulatory roles in FDA-regulated industries.
• Strong knowledge of FDA regulations and ISO standards.

Responsibilities

• Develop and conduct audits to ensure compliance with regulatory standards.
• Create detailed reports on audit findings and corrective actions.

Skills

Regulatory Compliance

Audit Planning

Technical Writing

Communication Skills

FDA Regulations Knowledge

ISO Standards Knowledge

Education

Bachelor's Degree in Science or Engineering

Tools

Microsoft 365

Job description

Join to apply for the Regulatory Auditor role at MTF Biologics.

Overview

The Regulatory Auditor position ensures that MTF complies with all applicable standards and regulatory requirements. The role involves planning and conducting internal process/product audits and external assessments of suppliers critical to the business. Key responsibilities include independently coordinating audits, developing audit plans, performing audits, and authoring reports that reflect findings, corrective/preventive actions, and their effectiveness.

This is a hybrid position located in Edison, NJ, requiring local presence and travel between NJ and PA for audits.

Salary: $78,400

Responsibilities

1. Develop audit plans, perform audits, and create reports on internal operations, ensuring compliance with procedural, standard, and regulatory requirements (cGMP, QSR, cGTP, ISO, MDSAP, AATB).
2. Develop audit plans, perform audits, and create reports on suppliers, ensuring compliance with regulatory, standards, and MTF requirements.
3. Partner with SQMT to confirm requirements for supplier evaluations and audits.
4. Assist in hosting and facilitating audits from regulatory agencies, accreditation bodies, and customers.
5. Make decisions on corrective and preventive actions and evaluate their effectiveness.
6. Conduct training on ongoing compliance topics as provided by Regulatory Affairs.
7. Maintain knowledge of new/revised regulations and review procedures for updates.
8. Assist on special projects and perform other duties as assigned.

Qualifications

1. Bachelor's degree in science, engineering, technology, or a related health field, or equivalent experience.
2. At least 3 years of quality or regulatory responsibility in an FDA-regulated industry.
3. Preferred certifications: CQNCQE, CTBS, Exemplar Global, or similar.
4. Excellent communication, organizational, and technical writing skills; proficiency in Microsoft 365.
5. Strong knowledge of FDA regulations and ISO standards.
6. Ability to communicate, prioritize, and organize effectively.
7. Ability to travel to PA.

Benefits include

• 4 weeks PTO, paid holidays, comprehensive health insurance, 401K with match, disability, life insurance, tuition reimbursement, flexible spending accounts, adoption assistance, voluntary benefits, and at-home physical therapy services.