Regulatory Compliance Manager

at  Munchkin Inc

WHO WE ARE:

WHY Brands Inc., a parent company of Munchkin and Curio Home Goods, focuses on creating, incubating, and growing the next generation of consumer lifestyle brands. Founded in 1990, Munchkin is the leading consumer product company and most loved baby lifestyle brand behind innovative gear and products for children, mothers, and caregivers. Munchkin has sold billions of dollars of products through our key retail partners: Target, Walmart, and Amazon, and has global distribution in over 50 countries. Curio, a premium brand of curated collections of home goods, launched in 2023. WHY’s vision is to establish an expanding portfolio of innovative businesses that align with its commitment to inventive product design. With over 320+ patents under our belt, we continue to create solutions that leave our customers asking, “How did I ever live without this?” Recognized as #8 on America’s Most Innovative Companies list by Fortune Magazine, innovation is the core of our company DNA and has been driving our designs for 30 years!
We lead with our core values and believe that investing in the community is our responsibility. We create opportunities for every child’s potential and well-being through the Radiant Colors program, work to create a sustainable future, and in partnership with the International Fund for Animal Welfare have committed to animal conservation.
There is no better time than now to join WHY Brands as we embark on our next and biggest growth journey, and you could be the next influential leader to play a key role in driving enormous customer-centered value and rapid growth.

POSITION SUMMARY:

The Regulatory Compliance Manager will ensure compliance with quality standards and drive continuous improvement initiatives to ensure product quality, efficiency, and customer satisfaction. This position will oversee quality assurance programs designed to ensure quality production of Munchkin products consistent with established standards and global regulations. In addition, this position is responsible for providing technical leadership for all aspects of quality engineering and product safety throughout the product realization process, including daily management of the quality assurance team and for overseeing regulatory compliance and related matters.

• Maintain and manage Munchkin’s quality systems and programs to ensure compliance with all applicable regulations, laws and standards
• Develop and implement regulatory strategies to ensure compliance with FDA regulations and guidelines
• Stay updated with changes in FDA regulations and guidance documents, and assess their impact on the company’s products and operations
• Oversee the preparation, review, and submission of regulatory filings such as New Medical Device registration and Premarket Notifications (510(k))
• Maintain and update regulatory files and databases, ensuring that all documents are accurate, complete, and filed in a timely manner
• Conduct internal audits and prepare the company for FDA inspections
• Review and approve product labeling, promotional materials, and advertising to ensure compliance with FDA regulations
• Ensure products are consistently produced to specifications to meet safety, quality and regulatory requirements
• Develop and implement comprehensive quality management system aligned with standards
• Collaborate with Product Development, Quality Assurance, Engineering, Marketing, and other departments to ensure compliance with regulatory requirements throughout the product lifecycle
• Conduct on-going staff trainings on applicable laws, regulations, standards, and company policies
• Represent and handle regulatory administration matters including application filing, renewals of licenses, and communications with agencies, notified entities, testing labs, etc
• Preparation and full working knowledge of technical files for all products intended for global distribution
• Respond to regulatory body enforcement inquiries and drive the investigation of all customer complaints and product failure, to facilitate resolution as well as implementation of corrective and preventive actions
• Provide training, mentoring, and development for Quality Assurance staff including Document Control Specialist and Quality Assurance Inspector(s) in the performance of their duties
• Participate in annual management reviews
• Prepare or monitor trend analyses for returns and complaints
• Prepare quarterly review reports
• Develop key performance indicators (KPIs) for quality and monitor performance
• Report on quality metrics, trends, and improvement initiatives to senior leadership
• Lead and oversee continuous process improvement initiatives
• Other duties may be assigned