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GlyMed Plus

Regulatory Compliance Manager

GlyMed Plus, Pleasant Grove, Utah, United States, 84062

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This range is provided by GlyMed Plus. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range

$82,982.00/yr - $94,982.00/yr Direct message the job poster from GlyMed Plus Vice President Accounting & Finance at GlyMed Plus

GlyMed Plus, a longtime leader in the skincare industry, is currently looking to add a Regulatory Compliance Manager to our team at our Corporate Facility. In business for over 30 years, GlyMed Plus continues to be an industry leader producing the most medically effective professional products and offering the most growth and new business focused vision in the industry. If you have a strong drive to be successful and want to work for a leader in the industry we want to hear from you! GlyMed Plus has launched many innovations in the past two years including new technologies, business processes and new products. There has never been a better time to join our growth-focused company! About the Role: We are seeking a detail-oriented and knowledgeable Regulatory Compliance Manager to ensure our skincare products and operations meet all relevant regulatory, legal, and ethical standards. This role plays a key part in overseeing compliance with FDA, Department of Agriculture, international cosmetic regulations, labeling laws, and internal quality policies to ensure consumer safety and brand integrity. As the Regulatory Compliance Manager you are responsible for ensuring that the organization complies with regulations guiding product manufacturing, packaging, labelling, safety, and quality standards. Your objective is to ensure that the company adheres to both internal and external product quality regulations and standards by conducting product life cycle audits from pre-production samples to customer-returned products. This role will involve the documentation of product quality complaints (PQC) from customer-facing departments into the QA database, where they will review, analyze, identify, and report complaint data and trends. You will then use this information to review the defective product samples and work with manufacturing companies, packaging companies, and even the GlyMed warehouse to refine processes and mitigate further opportunities for risk. This role also involves the organization, filing, and maintenance of technical documents and product information for the primary packaging, secondary packaging, and the finished goods to ensure the information on the products technical documents is well represented on the primary and secondary packaging. Responsibilities: Reviews inbound and outbound product documentation, processes, and practices. Lead product registration and notification processes in domestic and international markets. Monitor and ensure compliance with applicable regulations including MoCRA, FDA (21 CFR), EU Cosmetics Regulation, Health Canada, CBD and other global markets. Serve as liaison with regulatory authorities and certification bodies. Develops and enacts regulatory compliance strategies. Coordinates regulatory compliance procedures across organizational structures. Maintain SDSs (Safety Data Sheets), COAs, ingredient documentation, and technical files. Communicates compliance protocols and measures to management and relevant authorities. Manages complaints and technical issues relating to product design, packaging, and manufacturing. Conduct regular audits and risk assessments to identify gaps and corrective actions. Stay up to date with changes in skincare industry regulations and communicate key updates to stakeholders. Ensures that the organization complies with outside regulatory and legal requirements, as well as internal policies and bylaws. Collaborate with R&D, Marketing, and Legal teams on new product development from a compliance perspective. Works hand in hand with management and staff to identify and manage regulatory risk. Creates sound internal controls and monitors adherence to them. Manage adverse event reporting and oversee product recalls, if necessary. Proactively auditing processes, practices and documents to identify opportunities for risk. Review product formulations, packaging, labeling, marketing materials, and digital content to ensure regulatory compliance, and review of product related SOPs Obtain all licenses, permits and certifications, as required Maintain all legal/regulatory postings required by the state/federal government Work with manufacturing to initiate and process all outside testing, including ORAC, microbial, stability and Investigate and respond to deviations found during all processes Research and communicate safety and compliance requirements relating to current products, and new product categories Take part in Product Quality Risk Assessments projects to spot and quantify safety and quality risks, and develop mitigation plans Ensure that safety and compliance requirements are met in aspects of a product such as labeling, packaging artwork, and instruction booklets Assist in cost savings and continuous improvement projects to ensure that product safety and compliance is maintained Stay abreast of changes to regulatory and agency requirements, and recommend actions required to maintain compliance with active products, domestically and internationally Plan and execute ongoing testing, audits, and compliance documentation updates for active products Maintain records to support safety, compliance, quality, and accuracy of product information. Support the investigation and problem solving for safety or compliance issues Contribute to policies and processes to assure safety and compliance Other duties and responsibilities as assigned. Requirements: Bachelors degree in Regulatory Affairs, Life Sciences, Chemistry, or a BS in a related field. 5+ years related product management, quality assurance, product compliance, and or regulatory with demonstrated experience in assuring product compliance with regulatory requirements, and knowledge of product development and manufacturing. It is also vital to have knowledge of consumer products and the product life cycle. Strong project management skills within an environment of autonomy, effective communication skills, and problem-solving ability Strong knowledge of FDA regulations, INCI labeling, claims substantiation, and international compliance standards. Managed international regulatory affairs from formulas review & reformulations, product labeling, regulatory product documents process to final product registrations. Proficient and skillful in data entry and Microsoft Office applications, such as Excel & PowerPoint and project management software. Experience in establishing and monitoring safety protocols and procedures and documentation of standard operating procedures. Effective problem solver using problem-solving techniques and strategies, including root cause analysis, 8D, 5Why, PDCA methodologies, etc. Excellent communication, project management, and analytical skills. Attention to detail and ability to work cross-functionally in a fast-paced environment. Ability to anticipate and or curious to recognize and resolve potential safety and compliance issues before they occur Efficiently organized to manage a large volume of complaints, requests, and or documentation and processing them through the QA database. Job Type: Full-time 401(k) 401(k) matching Employee assistance program Health insurance Life insurance Paid time off Vision insurance Schedule: 8 hour shift Monday to Friday No nights Work Location: In-person Seniority level

Mid-Senior level Employment type

Full-time Job function

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