Regulatory Specialist

Clark Associates; Lancaster (Lancaster County); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Clark Associates in Lancaster, PA is seeking a Regulatory Specialist to support the company’s regulatory program. This role reviews product documentation and test reports, applies technical requirements, and helps ensure products meet US regulatory standards.

The successful candidate will monitor evolving regulations, perform risk assessments, review submissions, and collaborate with procurement, quality, and legal teams to maintain ongoing compliance across the product lifecycle.

Formación

• Review product documentation and test reports for compliance.
• Apply regulatory requirements to product files.
• Support regulatory submissions and lifecycle compliance.

Responsabilidades

• Monitor emerging regulations and standards; proactively recommend changes to ensure ongoing compliance.
• Conduct regulatory risk assessments for assigned product categories, collaborating with procurement, quality, and legal teams.
• Review test reports, technical specifications, and regulatory submissions for a diverse range of products.
• Verify that suppliers provide complete, accurate compliance documents (test reports, self-declarations) throughout the product lifecycle.
• Contribute to the development and continuous improvement of compliance policies and workflows.
• Serve as a technical resource and subject matter expert for internal stakeholders.

Conocimientos

Regulatory compliance

Regulatory risk assessment

Documentation review

Cross-functional collaboration

Descripción del empleo

Job Summary

A Regulatory Specialist supports the company's regulatory program by reviewing product documentation and test reports, applying technical requirements, and helping ensure products meet US regulatory standards.

Responsibilities

• Monitor emerging regulations and standards; proactively recommend changes to ensure ongoing compliance.
• Conduct regulatory risk assessments for assigned product categories, collaborating with procurement, quality, and legal teams.
• Review test reports, technical specifications, and regulatory submissions for a diverse range of products.
• Verify that suppliers provide complete, accurate compliance documents (test reports, self-declarations) throughout the product lifecycle.
• Contribute to the development and continuous improvement of compliance policies and workflows.
• Serve as a technical resource and subject matter expert for internal stakeholders.