Bonafide Health · 1 week ago
Director, Regulatory Affairs & Compliance
United States
Full-time
Remote
Director/Executive
$143K/yr - $239K/yr
10+ years expBonafide Health is focused on championing women's health through its brands. The Director of Regulatory Affairs & Compliance will ensure regulatory compliance of the company's products in the US and provide guidance on product classifications within the pipeline.
BiotechnologyE-CommerceHealth Care
No H1B
Responsibilities
Review product formulas and raw materials for compliance with applicable regulatory requirements, including ascertaining the regulatory classification of any proposed new products, and help generate new and updated product labels including food/supplement facts panel, ingredient statements and allergen statements ensuring compliance with regulations
Review and approve label artwork, graphics and text as well as marketing assets and website claims with a high level of detail for accuracy
Collaborate with multiple functions and support innovation projects and new product development
Monitor US and global regulatory legislation and provide the team with regular updates
Assist with the implementation of programs, policies, SOPs and practices to ensure products comply with appropriate regulations
Qualification
Required
Minimum 10 years of experience in Regulatory within the dietary supplement and/or food industry
Working knowledge of Dietary Supplement Health and Education Act (DSHEA)
Working knowledge of 21 CFR Parts 110, 111, 117, 190, 201, 314, 329, 330, 701, 801, and 814
Knowledge of current FDA and FTC guidance documents and enforcement policies within the food and dietary supplement industries
Experience managing FDA 510(k) and ANDA submissions a plus
Experience in working with finished products
Ability to understand and interpret clinical trial reports, medical journal articles and other medical/scientific materials that support product claims
Ability to read and interpret regulations, guidance documents, technical manuals, handbooks, formulations, and product specifications
Demonstrated ability to be proactive, independent, highly motivated, and effective in managing multiple projects, including outside consultants and counsel
Excellent communication skills with the ability to clearly communicate orally and in writing
Excellent planning, prioritizing and organizational skills
Highly proficient with corporate software tools - Microsoft office suite including Word, Excel, PowerPoint
Bachelor's degree or higher, preferably in life sciences or related area
Benefits
Annual performance bonus
Medical, dental and vision benefits
401K match
Other wellness benefits
Company
Bonafide Health
Bonafide Health is a women’s health company that develops and manufactures nutraceutical and health products for menopause issues.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$25M2023-11-30Acquired
2021-01-01Debt Financing· $25M
Leadership Team
A
Alyssa Dweck
Chief Medical Officer
Recent News
2025-10-17
Bonafide® Health, LLC
2025-09-12
2025-09-09
Company data provided by crunchbase