JOB SUMMARY:The Regulatory Affairs Manager is responsible for U.S. regulatory strategy, compliance, and lifecycle management for assigned medical device and over-the-counter drug products. The position serves as the primary Regulatory Affairs partner for assigned product portfolios and provides practical, timely guidance across product development, labeling and claims, manufacturing and supplier changes, quality-system activities, and ongoing FDA compliance. The role requires strong working knowledge of U.S. medical device requirements, including Class I and 510(k)-exempt devices, as well as OTC drug requirements, including applicable OTC monographs and administrative orders. This is a hands-on role requiring independent regulatory judgment, strong cross-functional partnership, and the ability to manage multiple priorities in a consumer healthcare environment.
MAJOR RESPONSIBILITES/ACTIVITES:Portfolio ownership and regulatory strategy (25%)- Serve as the primary U.S. Regulatory Affairs lead for assigned medical device and OTC drug products and develop practical regulatory strategies that support compliant product maintenance, innovation, and growth. At the Manager level, independently manage assigned portfolios and escalate significant regulatory issues to the Director. At the Sr. Manager level, lead broader or more complex portfolios and the development and execution of strategies for significant regulatory issues, in consultation with the Director.
- Provide clear regulatory recommendations, identify risks and options, and escalate significant issues with proposed paths forward.
Labeling, claims, advertising, and product development (25%)- Review product labeling, Drug Facts, device labeling, packaging, claims, advertising, promotional materials, and e-commerce content for compliance and adequate substantiation.
- Partner with Marketing, Legal, Medical/Clinical, Product Development, Package Development, and Graphics from concept through commercialization.
- Assess new products, line extensions, formula or material changes, and claim changes to determine the appropriate regulatory pathway and documentation.
FDA compliance and lifecycle maintenance (20%)- Maintain compliance for assigned OTC monograph drugs, including applicable establishment and drug listing activities, labeler-code/NDC information, annual certifications, and supporting regulatory records.
- Maintain medical-device regulatory obligations for assigned products, including establishment registration, device listing, classification assessments, and documentation supporting 510(k)-exempt status or any required premarket strategy.
- Monitor relevant FDA regulations, OTC monograph administrative orders, guidance, and industry developments; assess business impact and communicate required actions.
Change control, technical documentation, and quality-system support (20%)- Provide documented regulatory impact assessments for formula, specification, supplier, CMO, manufacturing process, component, packaging, labeling, and distribution changes.
- Maintain or oversee regulatory sections of product technical files and ensure regulatory decisions, claims support, and product status documentation are current, controlled, and retrievable.
- Partner with Quality on change controls, deviations, complaints, CAPAs, recalls or corrections, risk-management activities, quality agreements, and regulatory inspection readiness, as applicable.
- Support regulatory evaluation of CMO and supplier changes, product transfers, and other significant lifecycle activities.
Cross-functional leadership and operational excellence (10%)- Represent Regulatory Affairs on assigned brand, innovation, supply, quality, and commercialization teams; establish realistic timelines and deliver regulatory work on schedule.
- Build effective working relationships across functions and with external manufacturers, suppliers, laboratories, and consultants.
- Develop or improve procedures, tools, trackers, and training that strengthen compliance, transparency, and efficient portfolio management.
REQUIREMENTS:- Bachelor's degree in a scientific, engineering, pharmacy, health-related, or other relevant discipline; advanced degree preferred.
- Direct U.S. Regulatory Affairs experience with medical devices is required. Experience with OTC drug products is strongly preferred. Experience managing products across both medical device and OTC drug regulatory frameworks is a plus.
- Demonstrated experience independently managing assigned products or portfolios through development, commercialization, and post-market lifecycle activities.
- Experience working in a cross-functional, matrixed environment and communicating regulatory decisions to technical and non-technical stakeholders.
REQUIRED KNOWLEDGE AND SKILLS:- Strong working knowledge of U.S. medical-device requirements, particularly Class I devices, 510(k) exemptions, establishment registration, device listing, labeling, quality-system expectations, and change assessments.
- Strong working knowledge of U.S. OTC monograph drug requirements, including Drug Facts labeling, applicable monographs/administrative orders, FDA drug registration and listing, NDC-related maintenance, and annual certification obligations.
- Experience reviewing claims and substantiation, labeling, advertising, promotional materials, and digital/e-commerce content.
- Ability to assess product, process, supplier, specification, component, and labeling changes and clearly document the regulatory rationale and required actions.
- Working knowledge of quality-system interfaces, including change control, complaints, CAPA, risk management, document control, and CMO/supplier oversight.
- Strong written and verbal communication, organization, prioritization, and follow-through skills.
- Ability to work independently, exercise sound regulatory judgment, manage competing deadlines, and provide clear, business-focused recommendations.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and electronic document or quality systems.
Travel: 5% ability to travel via car, plane, rail.
LANGUAGE SKILLS: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
REASONING ABILITY: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
#HybridWork: We follow a Hybrid work schedule. All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).
Salary range: Manager Level: $125,000 - $140,000Work Hours: 40 hours per week.
