Sr. Director, Global Regulatory Affairs at Plexus Worldwide

Scottsdale, Arizona, United StatesFull-timeRegulatory AffairsPosted about 1 month ago

About the Role

<div> <div> <div> <div id="message-list"> <div id="message-list"> <div> <div> <div> <div id="message-list_1774285746.300319"> <div> <div> <div> <div> <div> <div> <div> <div> <div> <div> The role The Senior Director of Regulatory Affairs leads Plexus’ global regulatory and quality strategy, championing compliance while unlocking product innovation and international expansion. This role partners cross-functionally to support business growth, accelerate market entry, and maintain best-in-class product quality and regulatory excellence across all markets. Employee value proposition <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Opportunity to lead global expansion into new and emerging international markets</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Ability to build and modernize regulatory infrastructure, including QMS and AI-enabled tools</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">High visibility role with direct impact on company growth and product innovation</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Join a fast-growing organization where you can shape strategy, processes, and team capabilities</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Work in a dynamic environment where you are doing new things in new markets</li> </ul> Key performance objectives (What Success Looks Like in Year 1) <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Successfully implement a new Quality Management System (QMS) to enhance compliance and scalability.</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"> Integrate AI-enabled capabilities into existing regulatory software and tools to enhance process efficiency, improve data accuracy, and accelerate end-to-end regulatory workflows.</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Maintain and elevate product quality standards across all categories and markets</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Accelerate international product approvals, enabling faster entry into key global markets</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Strengthen regulatory partnership with Operations, Sales, and Marketing to support business growth initiatives</li> </ul> Key accountabilities Regulatory strategy & compliance <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Develop and execute global regulatory strategies and roadmaps that are created to align with market trends, legislation, product marketing objectives, and stay current on evolving regulations to advise senior leadership on strategic decisions.  </li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Ensure compliance with U.S. and international regulations across dietary supplements, foods, cosmetics, and OTC products</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Serve as primary liaison with FDA, international agencies, and auditors, including leading meetings and negotiations.</li> </ul> Global market expansion <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Lead cross-functional review and approval of product formulations for international market expansion, assessing regulatory compliance, ingredient permissibility, and labeling requirements by country; identify and validate acceptable alternative ingredients to ensure continuity of supply while maintaining product integrity and compliance with local regulations. Partner with International, Operations, Sales, and Marketing to accelerate product approvals and market entry timelines</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Monitor evolving global regulations and proactively guide business decisions</li> </ul> Product development & claims <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Provide regulatory guidance early in the product development lifecycle</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Review and approve product claims, labeling, and marketing materials</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Maintain international substantiation for all product claims</li> </ul> Operational excellence & systems <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Implement and optimize a Quality Management System (QMS)</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Drive adoption of AI-supported regulatory tools and process improvements</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Establish efficient workflows for regulatory reviews, labeling, and submissions</li> </ul> Leadership & team development <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Lead, mentor, and develop high-performing regulatory and quality teams</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Foster a culture of accountability, collaboration, and continuous improvement</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Provide regulatory and quality training and insights across the organization</li> </ul> Cross-Functional influence <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Build strong relationships with executive leadership and key stakeholders</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Influence decision-making to ensure compliant innovation and market readiness</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Support organizational change and scalability through regulatory and quality excellence</li> </ul> Performance qualifications <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Bachelor’s degree in Chemistry, Biology, or related scientific field (or equivalent experience)</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">8+ years of progressive regulatory experience in dietary supplements, food, cosmetics, or OTC products, including international markets</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">5+ years of leadership experience managing regulatory teams (10+ years preferred in team leadership environments)</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Strong knowledge of U.S. regulatory and quality requirements, including 21 CFR Parts 111 and 117, and global regulatory frameworks</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Experience managing regulatory submissions, labeling, and approvals across key international markets (e.g., US, Canada, Mexico, Australia, Korea, Japan, Brazil, Germany, UK)</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Deep understanding of product development, formulation, claims substantiation, and compliant marketing practices</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Proven ability to implement regulatory and quality systems, processes, or tools (e.g., QMS, automation, AI-enabled solutions)</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Strong analytical, problem-solving, and decision-making skills with the ability to interpret scientific and regulatory data</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Excellent communication and stakeholder management skills, with experience influencing cross-functional teams and executive leadership</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Ability to manage multiple priorities, navigate ambiguity, and operate effectively in a fast-paced, growth-oriented environment</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Experience working with regulatory agencies, auditors, consultants, and trade organizations</li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="message-list_bottomSpacer"></div> </div> </div> </div> </div> </div> </div> </div> </div> About Plexus Founded in gut health. Experts in microbiome. Plexus Worldwide®, headquartered in Scottsdale, Arizona, is a renowned direct-selling company recognized as a top employer. Over the past 18 years, Plexus has dedicated itself to promoting hope, health, and happiness through its scientifically backed, innovative dietary supplements, weight management products, and personal care products, sold primarily through Plexus Brand Ambassadors. As a six-time Best Places to Work awardee, Blue Zone-approved employer, and an AZ Most Admired Company, Plexus prides itself on its robust organizational culture and commitment to community support and philanthropy.  Our team is driven by a shared mission to empower individuals to achieve their health and wellness goals while offering additional income through the sale of products. Join us to be part of a team that values people, innovation, wellness, and community impact. Our Core Values We contribute to the overall growth and success of Plexus by embracing the Plexus core values: <ul> <li>We are One Plexus.</li> <li>We are accountable.</li> <li>We get the job done right.</li> <li>We empower others.</li> </ul> Benefits <ul> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Highly rated and competitive medical plans.</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">401 (k) with company match and immediate vesting.</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">1-on-1, personalized health coaching.</li> <li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Many other voluntary benefits.</li> </ul> To learn more about Plexus Worldwide, go to <a href="https://plexusworldwide.com/careers">https://plexusworldwide.com/careers</a>. Thank you for taking the time to apply for an opportunity with our One Plexus team! 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