Regulatory Affairs Manager

Sterling Engineering; Gloucester (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Annual bonus potential

Job summary

Sterling Engineering is seeking an experienced Regulatory Affairs leader to oversee regulatory compliance, labeling, food safety, and product commercialization for North American operations. This role acts as the SME on FDA/CFIA and related requirements, partnering with Quality, R&D, Marketing, and Leadership to ensure compliant products and effective crisis management.

The ideal candidate will lead recall readiness, maintain import/export compliance, and guide cross-functional teams through

Qualifications

• Bachelor's degree in a related scientific discipline.
• 10+ years in regulatory affairs or FSQA leadership in food manufacturing.
• Strong knowledge of FDA, CFIA, FSMA, labeling, and claims.
• Experience with audits, recalls, traceability, and import/export.
• Proven leadership and cross-functional collaboration.

Responsibilities

• Lead regulatory programs for U.S., Canada and international food regulations.
• Monitor regulatory changes, recalls and enforcement to mitigate risks.
• Collaborate with R&D, Marketing, Quality and Operations on formulations and labeling.
• Oversee import/export documentation and international trade compliance.
• Liaise with regulators, legal, industry groups and stakeholders on food safety matters.
• Lead crisis management, recalls and mock drills.
• Develop regulatory training and support audits and fraud prevention.
• Provide regulatory support for customers, sales teams and inquiries.

Skills

Regulatory leadership

FDA regulations

Food labeling

Product recall

Cross-functional collaboration

Education

Bachelor's degree in Food Science / Microbiology / Public Policy

Tools

Regulatory documentation systems

Job description

Bonus/ Incentives/ Stock Options: Annual Bonus Potential

Must have Skill Set:

• 10+ years of regulatory affairs or FSQA leadership experience within food manufacturing.
• Strong expertise in FDA regulations, food labeling, ingredient compliance, and regulatory claims.
• Experience leading product recall, crisis management, and traceability programs.
• 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.