Product Regulatory Compliance Specialist

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

The Regulatory Compliance Certification Specialist ensures that the organization complies with all relevant regulations, standards, and certification requirements within its industry. This role involves interpreting regulatory frameworks, managing compliance programs, and overseeing certification processes to minimize risk and maintain organizational integrity. The specialist works closely with cross-functional teams to implement and maintain compliance strategies, ensuring operational processes align with applicable laws, regulations, and certifications.

Key Responsibilities

• Regulatory Monitoring and Analysis
• Monitor and analyze changes in laws, regulations, and standards applicable to the organization.
• Maintain expertise in relevant industry regulations, including international, federal, state, and local laws.
• Assess the impact of regulatory changes on organizational policies and procedures.
• Compliance Program Management
• Develop, implement, and manage compliance programs to meet regulatory and certification requirements.
• Scheduling and tracking of activities required to acquire certificates in the time frame needed for customer demand. Regularly communicate progress via written and oral means to team members and other stakeholders.
• Conduct regular internal audits to ensure ongoing compliance.
• Collaborate with teams to address and resolve compliance gaps or risks.
• Certification Processes
• Lead and manage certification applications, renewals, and audits with regulatory bodies and certification agencies.
• Prepare necessary documentation, reports, and evidence for certifications.
• Serve as the primary point of contact during certification inspections and audits.
• Training and Communication
• Educate employees and management on regulatory requirements, certifications, and compliance best practices.
• Develop and deliver training materials to ensure consistent awareness of compliance obligations.
• Communicate compliance updates and policy changes to stakeholders.
• Risk Management
• Identify potential compliance risks and develop strategies to mitigate them.
• Monitor the effectiveness of risk mitigation measures and update them as needed.
• Reporting and Documentation
• Maintain detailed records of compliance activities, including audit results and certifications.
• Prepare regular compliance status reports for senior management and regulatory bodies.
• Document processes, policies, and procedures to support compliance activities.
  
  

Key Competencies

• Attention to detail and accuracy.
• Ability to handle confidential and sensitive information.
• Proactive and able to work independently or in teams.
• Strong leadership and project management skills.
  
  

Job Qualifications

• BS in Electrical Engineering, Mechanical Engineering, or equivalent experience.
• 2-3 years of experience in regulatory compliance, certification processes, or related role.
• Strong understanding of regulatory frameworks and certification standards in the industry.
• Excellent analytical, organizational, and problem-solving skills.
• Strong communication and interpersonal skills to collaborate with diverse teams.
• Certification in regulatory compliance or related fields (e.g., CRCM, Certified Regulatory Compliance Manager) is a plus.
• 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, etc.).
• Familiarity with Global Market Access certification.
  
  

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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