Regulatory Affairs Specialist

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.

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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. xhyhwjd
• Strong organizational skills and attention to detail, including the ability to manage multiple documentation requirements and regulatory deadlines.