Regulatory Compliance Manager

Canon-Business-Process-Services-f89af7fd; West Greenwich (RI); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive pay & benefits

Comprehensive training programs

Positive work and client environment

Employee discounts nationwide

Job summary

Canon-Business-Process-Services-f89af7fd seeks a Regulatory Compliance Manager to oversee FDA regulatory adherence and quality systems in a fast-paced environment in Rhode Island. You will develop programs, lead audits, and ensure CGMP, HACCP, ISO 9001 and ISO 13485 compliance across departments.

The role emphasizes cross-functional collaboration, training leadership, and rigorous documentation to support regulatory readiness and continuous improvement.

Qualifications

• Bachelor’s degree in a related field.
• 5 years experience in regulatory compliance and quality assurance testing and management.
• In-depth knowledge of FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485.
• Proven experience in project management with the ability to lead initiatives effectively.
• Excellent analytical and communication skills for cross-functional collaboration.

Responsibilities

• Develop, implement, and maintain compliance programs that align with regulatory requirements.
• Conduct quality audits to assess adherence to internal policies and external regulations.
• Monitor compliance with 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

HACCP

ISO 9001

ISO 13485

Project management

Analytical skills

Communication

Education

Bachelor’s degree in a related field

Job description

Overview

The Regulatory Compliance Manager will oversee and ensure adherence to regulatory standards within our organization. The ideal candidate will possess a strong background in quality management and compliance, with a focus on FDA regulations, CGMP, and various quality systems. This role is critical in maintaining the integrity of our operations and ensuring that all processes meet industry standards.

Responsibilities

• Develop, implement, and maintain compliance programs that align with regulatory requirements.
• Conduct quality audits to assess adherence to internal policies and external regulations.
• Monitor compliance with FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• Collaborate with cross-functional teams to ensure effective quality management practices are in place.
• 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.

Qualifications

• Bachelor’s degree in a related field.
• 5 years experience in regulatory compliance and quality assurance testing and management.
• Strong understanding of quality audits and quality management principles.
• In-depth knowledge of FDA regulations, CGMP, HACCP, ISO 9001, and ISO 13485 standards.
• Proven experience in project management with the ability to lead initiatives effectively.
• Excellent analytical skills with attention to detail for identifying compliance issues.
• Strong communication skills for effective collaboration across departments.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Proficiency in developing quality systems that support organizational goals.

What We Offer:

• Competitive pay & benefits!
• Comprehensive training and development programs that prepare employees to advance from within.
• A company focused on creating a positive work and client environment.
• Employee discounts on entertainment, products, and services nationwide!