Regulatory Affairs Specialist

Nesco Resource, LLC; New York (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Nesco Resource, LLC is seeking a Regulatory Affairs Specialist to support regulatory compliance, quality management systems, product registrations, and international market access. The role collaborates with quality, engineering, product development and other stakeholders to ensure regulatory requirements and industry standards are met.

The ideal candidate brings hands-on experience with regulatory submissions, audits, technical documentation, and product compliance across domestic and

Qualifications

• Experience in Regulatory Affairs, Quality Assurance, or related regulated field.
• Strong knowledge of GMP and quality management systems.

Responsibilities

• Prepare, review, and maintain regulatory documentation and product registration submissions for domestic and international markets.
• Manage regulatory registrations, product listings, and periodic reporting requirements.
• Prepare and maintain technical documentation and product files for market access and conformity assessment.
• Monitor regulatory changes and communicate implementation requirements to stakeholders.
• Provide regulatory guidance on product development, labeling, export requirements, and market-specific compliance.
• Review labeling and promotional materials for regulatory compliance.
• Maintain records of distributors, products, registrations, and renewal deadlines.
• Support regulatory submissions including premarket requirements and product clearances.
• Oversee quality management activities, document controls, SOPs, and training.
• Conduct internal audits and participate in regulatory inspections and third-party assessments.
• Maintain safety documents, testing records, and certification files for ongoing compliance.
• Identify and communicate quality or compliance issues and drive corrective actions.

Job description

An established organization operating in a regulated product environment is seeking a Regulatory Affairs Specialist to support regulatory compliance, quality management systems, product registrations, and international market access.

This role will work cross-functionally with quality, engineering, product development, and other internal stakeholders to ensure products and business processes meet applicable regulatory requirements and industry standards. The ideal candidate brings hands-on experience with regulatory submissions, quality systems, audits, technical documentation, and product compliance across domestic and international markets.

Key Responsibilities

Regulatory Affairs & Product Compliance

• Prepare, review, and maintain regulatory documentation and product registration submissions for domestic and international markets.
• Manage regulatory establishment registrations, product listings, and applicable periodic reporting requirements.
• Prepare and maintain technical documentation and product files to support applicable market access and conformity assessment requirements.
• Monitor changes in regulations, directives, and industry standards, assess their impact on business operations, and communicate implementation requirements to relevant stakeholders.
• Provide regulatory guidance on product development, design changes, labeling, export requirements, and market-specific compliance obligations.
• Review product labeling and promotional materials to ensure compliance with applicable regulatory requirements.
• Maintain records of approved international distributors, authorized products, registration status, and renewal deadlines.
• Provide regulatory support to affiliated business entities regarding applicable North American regulatory requirements.
• Support regulatory submission activities, including requirements applicable to premarket submissions and product clearances.

Quality Management Systems

• Oversee day-to-day quality management system activities, including document control, policy implementation, and compliance monitoring.
• Develop, review, and maintain standard operating procedures, work instructions, forms, and other controlled quality documentation.
• Support the implementation and maintenance of quality processes consistent with applicable regulatory requirements and good manufacturing practices.
• Conduct internal audits of quality systems, products, and production processes to assess compliance and identify opportunities for improvement.
• Coordinate and participate in regulatory inspections, quality system audits, and third-party compliance assessments.
• Maintain product safety documentation, testing records, and certification files to support ongoing compliance with applicable standards.
• Identify and communicate significant quality or compliance issues to management, recommending corrective actions and process improvements.
• Develop and deliver regulatory and quality systems training to employees.
• Prepare, analyze, and report quality metrics to support ongoing performance monitoring and continuous improvement.

Cross-Functional Collaboration

• Partner with product development, engineering, manufacturing, and other teams to incorporate regulatory and quality requirements throughout the product lifecycle.
• Communicate regulatory submission requirements and compliance expectations to cross-functional stakeholders.
• Support continuous improvement initiatives related to quality systems, documentation practices, and regulatory compliance.
• Perform other related duties as assigned.

Required Qualifications

• Three to five years of experience in Regulatory Affairs, Quality Assurance, Quality Systems, or a related function within a regulated industry.
• Working knowledge of good manufacturing practices (GMP) and quality management system requirements.
• FDA-regulated product requirements, including applicable U.S. and international regulatory frameworks.
• Experience preparing or maintaining regulatory documentation, controlled quality documents, or product compliance records.
• Understanding of regulatory audits, internal audits, and compliance monitoring processes.
• Strong written and verbal communication skills, with the ability to interpret regulatory requirements and communicate their practical implications to cross-functional teams.
• Strong organizational skills and attention to detail, including the ability to manage multiple documentation requirements and regulatory deadlines.