Regulatory Affairs Manager

Job Description

Job Description

Scope of Position

The Regulatory Affairs Manager is responsible for leading all necessary Regulatory and Compliancesupport for the North American corporate office and supporting, where needed, the global business. This role will ensure compliance with all applicable market requirementsgoverning medical device, cosmetic, OTC, and consumer products developed, manufactured, ordistributed by or on behalf of the company. The Manager will provide direction on productlabeling claims, maintain appropriate regulatory certifications, prepare and submit regulatorydocuments to regulatory authorities, and manage internal compliance. Lastly, the Manager willprepare and implement procedures to ensure compliance with regulations and policies.

Responsibilities

• Support Commercial and New Product Development functions in determining the regulatory strategyfor new product launches or changes to existing products, interpreting the associated regulations,and providing regulatory guidance.
• Oversee and manage Regulatory activities to ensure the technical accuracy, quality, andtimeliness of regulatory communications, submissions, registrations, and listings, including:
• Advise and direct 510(K) activity for the company's branded medical device products,supporting original manufacturers (and the company's subsidiaries) as required.
• File and maintain Medical Device Establishment Registration Listings.
• File and maintain MoCRA registrations for Cosmetic products.
• File and maintain OTC product registration and listings. Ensure HR operations alignwith organizational policies and regulatory requirements.
• Act as primary liaison between the company and the Regulatory Authorities (FDA, Health Canada, USDA, etc.).
• Assume Medical Device US Agent responsibility for the company's subsidiaries and other originalmanufacturers, as applicable.
• Coordinate regulatory issue resolution using internal resources, regulatory agencies, and outsideconsultants as necessary.
• Collaborate with Brand and New Product Development teams upfront on desired claims and support.
• Review and approve US artwork/labeling copy and assist the Global Packaging Team (GPT) inestablishing a Global Labelling Specification Manual (GLSM)and ensuring all labeling is consistent with it and also with the Claims Support Dossier (CSD).
• Own US retailer-specific product documentation filings (e.g. Walmart WERCS assessment).
• Oversee Canadian market registrations/listings and labeling activity undertaken by the in-country agent/distributor on the company's behalf.
• Work with external consultant(s) as necessaryand guide GPT in UDI label content, GUDID registration, and maintenance.
• Support the Regulatory function in compiling and maintaining a library/register of Laws,Regulations, Standards, and Guidance (LRSG) applicable to the company's products, and providing timely notification of new or revised LRSG and its potential impact onexisting products
• Support North America QA Team in establishing and managing the Regulatory aspects of the QualityManagement System (QMS).

Qualifications

Education

• Bachelors degree or equivalent in a scientific or health-related field.
• Certificates: Regulatory Affairs Certificate (RAC)

Experience

• 5+ years related regulatory experience with consumer goods in the medical devices,over-the-counter (OTCs), pharmaceuticals, dietary supplements, and/or cosmetics categories.
• Global experience in the UK, Europe, and other international geographies is a plus.
• In-depth knowledge of applicable laws, regulations, labeling claims, standards, and guidance.

Skills

• Strong knowledge of FDA regulations and requirements, monographs/labeling/ claim substantiationacross medical devices, over-the-counter (OTCs), pharmaceuticals, dietary supplements, and/orcosmetics categories.
• Must have a sense of urgency and be a visible leader in a fast-paced, rapid-growthenvironment.
• Solid operating skills, including timely decisions, managing, and measuring work, and goodoverall time and project management.
• Ability to work effectively individually and cross-functionally within a team.
• Demonstrated ability to collaborate and find solutions to complex challenges.
• Ability to think strategically, interpret, and act upon complex compliance requirements.
• Excellent communication (written and oral) and organizational skills, and attention to detail.
• Good interpersonal and negotiation skills.
• Ability to work and maintain collaborative relationships across borders and time zones witha manager in the UK.
• Proficient in Microsoft Office.