Regulatory Affairs Manager Jobs in USA with Visa Sponsorship

About us:

Magic Science Supply, LLC is a healthcare technology-based consumer products company specializing in the manufacturing of hypochlorous acid (HOCl), an antimicrobial disinfectant that kills 99.9% of germs.

We believe that keeping families healthy does not have to mean exposing them to harsh chemicals. Our CleanSmart, SkinSmart, and Magic Molecule brands use simple ingredients and smart science to effectively kill germs that make people sick.

Position Summary

The Regulatory Affairs Manager is responsible for leading and executing the organization’s regulatory strategy to ensure compliance with applicable FDA, EPA, and ISO 13485 requirements. This role provides regulatory leadership across the full product lifecycle, supporting both manufacturing and commercial operations, and serves as the primary regulatory interface with external agencies.

The ideal candidate brings 5–10 years of progressive regulatory experience, a strong understanding of regulated quality systems, and the ability to partner cross-functionally to enable compliant growth. This position will report directly to the VP of Operations.

Key Responsibilities

Regulatory Leadership & Submissions

• Lead and manage FDA regulatory submissions, including product registrations, listings, and applicable premarket submissions (e.g., 510(k), De Novo, EUA, as required).
• Manage EPA regulatory submissions, including registrations, amendments, renewals, and associated compliance activities.
• Develop and maintain regulatory strategies aligned with business objectives and product commercialization plans.
• Serve as the primary point of contact with regulatory authorities, including FDA and EPA.

Quality System & ISO 13485 Compliance

• Ensure ongoing compliance with ISO 13485 and applicable FDA Quality System Regulations (21 CFR 820 / QMSR).
• Collaborate with Quality Assurance to maintain and continuously improve the Quality Management System.
• Review and approve controlled documents, change controls, validations, and risk management activities to ensure regulatory compliance.
• Provide regulatory input into CAPA investigations, nonconformance management, and corrective action plans.

Audit & Inspection Management

• Lead regulatory activities during internal and external audits, including:
• FDA inspections
• ISO 13485 certification audits
• Customer and third-party audits
• Prepare the organization for regulatory inspections through readiness activities and internal assessments.
• Lead the development and execution of responses to audit observations and regulatory findings.

Cross-Functional Partnership

• Partner with Manufacturing, Engineering, Quality, R&D, and Supply Chain to ensure regulatory compliance throughout production and process changes.
• Collaborate with Commercial, Marketing, and Sales teams to review and approve labeling, promotional materials, and product claims.
• Provide regulatory guidance during product development, technology transfer, and commercialization activities.

Leadership & Communication

• Act as a regulatory subject matter expert and advisor to senior leadership.
• Establish and maintain scalable regulatory processes and procedures.
• Support training initiatives to ensure organizational awareness of regulatory requirements.

Qualifications

Required:

• Bachelor’s degree in a scientific, engineering, or related discipline.
• 5–10 years of regulatory affairs experience within FDA-regulated industries.
• Demonstrated expertise in:
• ISO 13485
• FDA medical device regulations (21 CFR 820 / QMSR)
• FDA submission processes and lifecycle management
• EPA regulatory compliance and submissions
• Proven experience leading regulatory audits and inspections.
• Strong written and verbal communication skills.

Preferred:

• Experience in medical devices, diagnostics, or regulated manufacturing environments.
• Experience supporting products regulated by both FDA and EPA.
• RAC or comparable professional certification.
• Experience operating in a cross-functional, matrixed organization.

Key Competencies

• Regulatory strategy and execution
• Audit and inspection leadership
• Cross-functional collaboration
• Risk-based decision making
• Attention to detail and documentation rigor
• Professional judgment and discretion

Job Type: Full-time

Pay: $150,000.00 - $160,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

People with a criminal record are encouraged to apply

Ability to Commute:

• Edina, MN 55439 (Required)

Work Location: In person

Magic Science Supply, LLC is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, veteran status, marital status, or any other status protected by applicable law.