As a Product Compliance Engineer, you will play a critical role in ensuring that products meet regulatory requirements, adhere to industry standards, and uphold the company's commitment to quality, safety, and compliance. Your primary objective will be to maintain the highest level of product safety, government compliance and mitigate potential hazards that could lead to customer harm or legal disputes.
There is a strong emphasis on technical aspects of this profession, scientific understanding, and strong project management. Professionals in this role expand their involvement in international/multinational regulatory issues and begin a more active involvement with concepts of regulatory strategy and people management. Your role involves collaborating with cross-functional teams, conducting thorough inspections and tests, and maintaining up-to-date knowledge of applicable laws and industry standards. By meticulously evaluating product designs, materials, and manufacturing processes, you will contribute to the development of safe, reliable, and legally compliant products. Your expertise will be instrumental in protecting both the company's reputation and the well-being of its customers.
A Product Compliance Engineer demonstrates knowledge and skills in areas such as, not limited to, regulatory frameworks; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, and post-marketing surveillance. Individuals in this role focus on hands-on training to strengthen and develop new skills and knowledge.
• Regulatory Compliance Assurance: Ensuring that all products meet the regulatory requirements and standards set by relevant authorities in the regions where they are sold or distributed. This includes monitoring changes in regulations, interpreting their implications for product design and manufacturing, and implementing necessary adjustments to maintain compliance.
• Risk Assessment and Mitigation: Identifying potential compliance risks associated with product design, materials, manufacturing processes, and usage scenarios. Developing and implementing strategies to mitigate these risks effectively, such as redesigning products, selecting alternative materials, or implementing additional safety measures.
• Product Testing and Evaluation: Planning, coordinating, and executing comprehensive testing programs to assess product safety and performance impact. This involves selecting appropriate testing methodologies, conducting tests in accordance with relevant standards and protocols, and analyzing test results to ensure compliance.
• Documentation and Record-Keeping: Maintaining accurate and up-to-date records of compliance activities, including test reports, certification documents, regulatory submissions, and correspondence with regulatory agencies. Ensuring that all required documentation is complete, organized, and readily accessible for audits, inspections, and reporting purposes.
• Cross-Functional Collaboration: Collaborating closely with internal teams, including product development, engineering, manufacturing, quality assurance, and legal departments, to integrate compliance considerations into the product lifecycle. Providing guidance and support to ensure that compliance requirements are understood and addressed throughout the development and manufacturing processes.
• Continuous Improvement: Proactively identifying opportunities to enhance compliance processes, procedures, and standards to ensure ongoing adherence to regulatory requirements and industry best practices. Implementing improvements and monitoring their effectiveness to drive continuous improvement in product compliance performance.
• Training and Education: Providing training and guidance to internal teams on compliance-related matters, including regulatory requirements, testing methodologies, and best practices for ensuring product compliance. Promoting a culture of compliance awareness and accountability throughout the organization through effective communication and education initiatives.
• Audit and Inspection Support: Supporting internal and external audits and inspections related to product compliance, including preparing documentation, facilitating interviews and site visits, and addressing any findings or non-compliance issues identified during the audit process. Implementing corrective and preventive actions as needed to address compliance deficiencies and prevent recurrence.