Regulatory Affairs Manager

Summary

Join our growing team of >275 people and help us build a future where all parents can feel amazing about feeding their baby—no matter how they do it. As the Regulatory Affairs Manager, you will oversee regulatory compliance for ByHeart’s product portfolio, ensuring accuracy and compliance with regulatory standards.

Requirements

• Bachelor’s degree in a relevant scientific or medical field
• 5+ years of experience in Regulatory Affairs within the Food, Pharmaceutical, or another regulated industry, with expertise in compliance; experience in the Infant/Toddler category is a plus
• Strong knowledge of US FDA regulations, compliance requirements, and product development processes; familiarity with international guidelines is beneficial
• Excellent analytical skills to interpret regulatory information and requirements accurately, ensuring compliance across all products
• Excellent interpersonal and communication skills to build effective cross-functional relationships, communicate regulatory updates, requirements, and guidance to internal stakeholders, and collaborate to achieve common objectives
• Strong project management and organizational skills, with the ability to manage multiple projects and deadlines while maintaining attention to detail
• High attention to detail to ensure accuracy in documentation, data analysis, and regulatory submissions

Responsibilities

• Interpret and apply regulatory requirements across product development, operational activities, and product lifecycle management to ensure compliance in domestic and international markets and support business objectives
• Lead the label development and review process and assess labels, claims, advertising, and promotional materials for regulatory compliance
• Support international regulatory compliance reviews and assessments to maintain global standards
• Develop, implement, and update policies, procedures, work instructions and forms related to Regulatory Affairs to ensure consistency and to promote a culture of regulatory compliance
• Maintain centralized document management system for Regulatory Affairs. Ensure all documents are available and accurate for auditing purposes
• Support the preparation, review, and organization of regulatory submission documentation to ensure accuracy, completeness, and compliance with regulatory standards
• Train internal teams on relevant regulations, directives, and standards to ensure organization-wide understanding and adherence
• Track and stay current with regulatory developments, assessing their impact on business operations and advising relevant teams to ensure timely compliance
• Act as the regulatory lead in change control reviews for plant processes, procedures, and label modifications to ensure compliance with regulatory requirements and standards
• Provide regulatory support for audits, inspections, recalls, and other compliance-related activities

Benefits

• Health insurance for the whole family : medical, dental, & vision insurance covered 100%, with 90% coverage for your family
• Flexible paid time off : plus 12+ company holidays, and 2 floating holidays to use at your discretion!
• 16-weeks of fully-paid parental leave and new parent support : free 1-year supply of formula, cozy feeding suites, and paid pumping time
• Up to 6% 401(k) Match to help you plan for your future
• Company equity for every employee : because when we succeed, we succeed together!