Regulatory Compliance Manager — FDA & Quality Systems

Canon U.S.A., Inc.; West Greenwich (RI); On-site; USD 117,000 - 143,000; Full time

Job summary

Canon U.S.A., Inc. in West Greenwich, RI is seeking a Regulatory Compliance Manager to oversee regulatory standards and quality systems, focusing on FDA regulations, CGMP, and ISO frameworks.

The role requires cross-functional collaboration to maintain product integrity and industry compliance. The ideal candidate holds a bachelor’s degree with 5+ years in regulatory compliance and QA, strong auditing and documentation skills, and proven project management ability to lead compliance initiatives

Qualifications

• Bachelor's degree in a related field.
• 5 years experience in regulatory compliance and QA testing/management.
• Strong understanding of quality audits and quality management.
• Knowledge of FDA regulations, CGMP, HACCP, ISO 9001, ISO 13485.
• Project management experience.
• Analytical skills with attention to detail.
• Strong cross-department communication.
• Ability to work independently and in a team.
• Develops quality systems to support organizational goals.

Responsibilities

• Develop, implement, and maintain compliance programs.
• Conduct quality audits to assess adherence to internal policies and external regulations.
• Monitor FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• Collaborate with cross-functional teams to ensure effective quality management practices.
• Lead training initiatives to educate staff on compliance protocols and quality assurance measures.
• Manage documentation related to quality systems and compliance activities.
• Identify areas for improvement within the compliance framework and propose actionable solutions.
• Prepare reports on compliance status and present findings to senior management.

Skills

Regulatory compliance

Quality audits

FDA regulations

CGMP

ISO 9001

ISO 13485

Project management

Analytical skills

Communication

Independent / team work

Education

Bachelor's degree in a related field

Job description

Canon U.S.A., Inc. in West Greenwich, RI is seeking a Regulatory Compliance Manager to oversee regulatory standards and quality systems, focusing on FDA regulations, CGMP, and ISO frameworks.

The role requires cross-functional collaboration to maintain product integrity and industry compliance. The ideal candidate holds a bachelor’s degree with 5+ years in regulatory compliance and QA, strong auditing and documentation skills, and proven project management ability to lead compliance initiatives