Job Description
Job Description
Title: Regulatory Manager (FDA)
Location: Gloucester, MA
Compensation: $105-120k
Bonus/ Incentives/ Stock Options: Annual Bonus Potential
Benefits: Medical, Dental, Vision, 401k
Must have Skill Set:
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10+ years of regulatory affairs or FSQA leadership experience within food manufacturing.
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Strong expertise in FDA regulations, food labeling, ingredient compliance, and regulatory claims.
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Experience leading product recall, crisis management, and traceability programs.
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Proven ability to partner with cross-functional teams to support product commercialization and regulatory compliance.
Overview:
A well-established food manufacturing organization is seeking an experienced Regulatory Affairs leader to oversee regulatory compliance, labeling, food safety, and product commercialization efforts across North American operations. This individual will serve as the subject matter expert on FDA, CFIA, and other regulatory requirements while partnering closely with Quality, R&D, Marketing, Operations, and Executive Leadership to ensure products meet all applicable regulations and industry standards. This role also leads crisis management and recall readiness initiatives while supporting global import/export compliance.
Job Duties:
- Lead regulatory compliance programs to ensure ingredients, products, packaging, and labeling meet U.S., Canadian, and applicable international food regulations.
- Monitor changing regulatory requirements, industry trends, recalls, and enforcement activities to proactively mitigate compliance risks.
- Partner cross-functionally with R&D, Marketing, Quality, and Operations to review product formulations, packaging, nutrition labeling, claims, advertising, and commercialization activities.
- Oversee import/export regulatory documentation, certification programs, and compliance with international trade requirements.
- Serve as the primary liaison with regulatory agencies, legal counsel, industry associations, and external stakeholders regarding food safety and regulatory matters.
- Lead corporate crisis management, product recall, and traceability programs, including annual mock recalls and crisis preparedness exercises.
- Develop and deliver regulatory compliance training while supporting food fraud prevention initiatives, third-party audits, and corporate responsibility programs.
- Provide technical documentation and regulatory support for customers, sales teams, and consumer inquiries.
Qualifications:
- Bachelor's degree in Food Science, Microbiology, Public Policy, Legal Studies, or a related scientific discipline.
- 10+ years of food industry experience with progressive responsibility in regulatory affairs, food safety, or quality leadership.
- Strong working knowledge of FDA, CFIA, FSMA, labeling regulations, food claims, and food regulatory requirements.
- Experience supporting regulatory inspections, audits, product recalls, traceability programs, and import/export compliance.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Experience working with regulatory documentation and compliance management systems.
- Ability to travel up to 20%.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.