Regulatory Compliance Manager

Canon U.S.A., Inc.

West Greenwich (RI)

On-site

USD 117,000 - 143,000

Full time

6 days ago
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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

Job Details

Regulatory Compliance Manager

Job Locations: US-RI-West Greenwich

Requisition ID: 2026-21737

# of Openings: 1

Category: Warehouse/Shipping

Position Type: Regular Full-Time

Fixed Salary: USD $130,000.00/Yr.

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!

Canon Business Process Services is committed to providing equal employment opportunities to all applicants for employment and employees and does not discriminate in employment on the basis of race, color, religion, religious creed (including religious dress and grooming practices), sex (including pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding or related medical conditions),gender, gender identity/transgendered status, gender expression, national origin (including language use), ancestry, citizenship status, age, marital status, familial status, physical and/or mental disability (including HIV/AIDS, cancer and genetic characteristics), protected medical condition as defined by applicable state and/or local law, military and/or veteran status, sexual orientation, genetic information, political affiliation, domestic violence victim status or any other protected category.

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