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For nearly 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

Job Summary

We are seeking a detail-oriented and knowledgeable Regulatory Compliance Engineer to ensure our products, processes, and operations comply with applicable regulations, standards, and internal policies. The ideal candidate works closely with cross-functional teams to implement and maintain compliance strategies, and interpret regulatory requirements, guide teams through compliance processes, and serve as a key liaison between internal stakeholders and regulatory bodies.

Key Responsibilities

+ Interpret and apply relevant regulatory and industry standards (e.g., ISO, FDA, RoHS, REACH, Conflict Minerals, CE, UL, FCC).

+ Develop, implement, and maintain regulatory compliance strategies and procedures.

+ Prepare and submit documentation for regulatory approvals and certifications.

+ Conduct internal audits and risk assessments to ensure ongoing compliance.

+ Liaise with regulatory agencies and notified bodies during inspections, audits, or inquiries.

+ Review engineering designs and product specifications for compliance from concept to production.

+ Collaborate with cross-functional teams (R&D, QA/QC, legal, manufacturing) to address compliance issues.

+ Monitor and report changes in regulatory environments and recommend necessary updates to processes.

+ Provide training and guidance to staff on regulatory requirements and best practices.

Job Qualifications

+ Bachelor's in engineering related discipline.

+ 4 - 6 years of experience

+ Proven experience in regulatory compliance, certification processes, or related role.

+ Strong understanding of regulatory frameworks and certification standards in the industry.

+ Experience working with regulatory agencies or certification bodies (TUV, UL, CSA, CE, etc).

+ Familiarity with industry-specific regulations (e.g., ISO standards, FCC, EMC/EMI, Safety, IEC 61010, etc.).

+ Strong communication and interpersonal skills to collaborate with diverse teams.

Preferred skills:

+ Certification in regulatory compliance or related fields (e.g., CRCM, Certified Regulatory Compliance Manager) is a plus.

+ Familiarity with Global Market Access certification.

Key Competencies:

+ Attention to detail and accuracy.

+ Excellent analytical, organizational, and problem-solving skills.

+ Ability to handle confidential and sensitive information.

+ Proactive and able to work independently or in teams.

+ Strong leadership and project management skills.

Travel:

+ 20% Domestic and International travel required.

Compensation Data

The pay range for this position is $110,000 to $120,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

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