About this opportunity
Nesco Resource lists this Regulatory Affairs Specialist opportunity in new suffolk, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Position Overview
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.
Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below.
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. xhmxlyz
Strong organizational skills and attention to detail, including the ability to manage multiple documentation requirements and regulatory deadlines.
Worksite address
new suffolk, NY, 11956, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.