Job Description
Job Description
Position Overview
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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.
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Key Responsibilities
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Regulatory Affairs & Product Compliance
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\n - Prepare, review, and maintain regulatory documentation and product registration submissions for domestic and international markets.
\n - Manage regulatory establishment registrations, product listings, and applicable periodic reporting requirements.
\n - Prepare and maintain technical documentation and product files to support applicable market access and conformity assessment requirements.
\n - Monitor changes in regulations, directives, and industry standards, assess their impact on business operations, and communicate implementation requirements to relevant stakeholders.
\n - Provide regulatory guidance on product development, design changes, labeling, export requirements, and market-specific compliance obligations.
\n - Review product labeling and promotional materials to ensure compliance with applicable regulatory requirements.
\n - Maintain records of approved international distributors, authorized products, registration status, and renewal deadlines.
\n - Provide regulatory support to affiliated business entities regarding applicable North American regulatory requirements.
\n - Support regulatory submission activities, including requirements applicable to premarket submissions and product clearances.
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Quality Management Systems
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\n - Oversee day-to-day quality management system activities, including document control, policy implementation, and compliance monitoring.
\n - Develop, review, and maintain standard operating procedures, work instructions, forms, and other controlled quality documentation.
\n - Support the implementation and maintenance of quality processes consistent with applicable regulatory requirements and good manufacturing practices.
\n - Conduct internal audits of quality systems, products, and production processes to assess compliance and identify opportunities for improvement.
\n - Coordinate and participate in regulatory inspections, quality system audits, and third-party compliance assessments.
\n - Maintain product safety documentation, testing records, and certification files to support ongoing compliance with applicable standards.
\n - Identify and communicate significant quality or compliance issues to management, recommending corrective actions and process improvements.
\n - Develop and deliver regulatory and quality systems training to employees.
\n - Prepare, analyze, and report quality metrics to support ongoing performance monitoring and continuous improvement.
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Cross-Functional Collaboration
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\n - Partner with product development, engineering, manufacturing, and other teams to incorporate regulatory and quality requirements throughout the product lifecycle.
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\n - Support continuous improvement initiatives related to quality systems, documentation practices, and regulatory compliance.
\n - Perform other related duties as assigned.
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Required Qualifications
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\n - Three to five years of experience in Regulatory Affairs, Quality Assurance, Quality Systems, or a related function within a regulated industry.
\n - Working knowledge of good manufacturing practices (GMP) and quality management system requirements.
\n - FDA-regulated product requirements, including applicable U.S. and international regulatory frameworks.
\n - Experience preparing or maintaining regulatory documentation, controlled quality documents, or product compliance records.
\n - Understanding of regulatory audits, internal audits, and compliance monitoring processes.
\n - Strong written and verbal communication skills, with the ability to interpret regulatory requirements and communicate their practical implications to cross-functional teams.
\n - Strong organizational skills and attention to detail, including the ability to manage multiple documentation requirements and regulatory deadlines.
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