Regulatory Compliance Manager — Growth-Focused QA & FDA Expert

Canon Business Process Services, Inc.; West Greenwich (RI); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive pay & benefits

Training and development

Positive work environment

Employee discounts nationwide

Job summary

Canon Business Process Services, Inc. seeks a Regulatory Compliance Manager to oversee adherence to FDA regulations, CGMP, and quality systems across the organization.

The role emphasizes strong QA leadership, documentation control, and cross-functional collaboration to maintain industry standards. The ideal candidate has a Bachelor's degree and at least five years of regulatory compliance and quality assurance management experience, with proven ability to drive improvements in a fast-paced

Qualifications

• Bachelor's degree required.
• 5 years experience in regulatory compliance and QA testing/management.
• Strong understanding of audits and quality management.
• Knowledge of FDA regulations, CGMP, HACCP, ISO 9001, ISO 13485.
• Proven project management experience.
• Analytical skills with attention to detail.
• Strong cross-functional collaboration and communication.
• Ability to work independently and in a fast-paced environment.

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 QA measures.
• Manage documentation related to quality systems and compliance activities.
• Identify areas for improvement within the compliance framework and propose solutions.
• Prepare reports on compliance status and present findings to senior management.

Skills

Regulatory compliance

Quality audits

Quality management

Project management

Analytical skills

Communication skills

Education

Bachelor's degree in a related field

Tools

Document control software

Quality management software

Job description

Canon Business Process Services, Inc. seeks a Regulatory Compliance Manager to oversee adherence to FDA regulations, CGMP, and quality systems across the organization.

The role emphasizes strong QA leadership, documentation control, and cross-functional collaboration to maintain industry standards. The ideal candidate has a Bachelor's degree and at least five years of regulatory compliance and quality assurance management experience, with proven ability to drive improvements in a fast-paced