Regulatory Compliance Manager

Canon Business Process Services

West Greenwich, RIFull-time$130K/yrPosted 1 day agoSeen in employer's feed today

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At a glance

Compensation

$130K/yr

Location

West Greenwich, RI

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Regulatory Compliance Manager oversees adherence to regulatory standards and maintains the integrity of organizational operations. The role focuses on quality management, FDA regulations, CGMP, and quality systems, ensuring processes meet industry standards. The ideal candidate has a background in compliance and quality assurance, along with experience leading projects and developing quality systems.

Skills & qualifications

RequiredNice to have

Skills

Quality ManagementRegulatory ComplianceQuality Assurance TestingQuality AuditsQuality Management PrinciplesFDA RegulationsCGMPHACCPISO 9001ISO 13485Project ManagementAnalytical SkillsAttention to DetailCommunicationTeamworkQuality Systems Development

Qualifications

Bachelor's in Related Field5 Years Experience

Benefits

Tuition Assistance

Full 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.