Regulatory Affairs Business Partner (Senior RA Specialist)

Scope Group

98d•$115,000 - $125,000•Remote

About The Position

Scope is seeking an experienced regulatory professional to own US regulatory affairs for its eye care portfolio, which includes OTC ophthalmic drug products marketed under the FDA OTC monograph, Class I/II medical devices, cosmetics, and dietary supplements. This is a senior, hands-on role for someone with US regulatory experience in OTC/consumer health and/or medical devices. The successful candidate will serve as the go-to US regulatory expert in a small, close-knit team, setting regulatory strategy, making decisions on pathways, labelling and claims, and guiding products from concept through launch and lifecycle management. The role works closely with Innovation, Product Development, Quality, Commercial, Marketing and Customer Care, helping bring products already successful in the UK and Europe to US patients and eye care professionals. It reports to the Senior Regulatory Affairs Manager. The position is remote and US-based, with occasional travel for team meetings and industry events. Candidates must be authorised to work in the US.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, Engineering, Regulatory Affairs, or a related discipline.
Hands-on US regulatory affairs experience in OTC/consumer health products and/or medical devices.
Direct experience with OTC monograph drug products, including Drug Facts labelling, monograph compliance, and drug listing (SPL).
Direct experience with US medical devices, including classification, establishment registration and listing, and preparing 510(k) submissions.
Track record of independently leading regulatory projects from concept to launch.
Strong working knowledge of FDA and FTC labelling, advertising, and claims requirements, with confidence to provide clear sign-off.
Experience managing correspondence with FDA.
Ability to cover several product categories in a lean team and serve as the go-to regulatory professional.
Excellent stakeholder management and communication skills, with the ability to influence commercial teams.
Candidates must be authorised to work in the US.

Nice To Haves

RAC (Regulatory Affairs Certification) or equivalent.
US-market ophthalmic product experience, such as lubricant eye drops, eyelid hygiene, or other eye care products.
Experience with sterile products, including ophthalmic sterility requirements.
Experience with cosmetics (MoCRA) and dietary supplements (DSHEA, structure/function claims).
Experience bringing UK/EU products to the US market or working with an international regulatory team.
Experience with FDA QMSR / ISO 13485 quality systems.
Experience in consumer health or FMCG environments, including retail and e-commerce channels.
Experience with AI, digital tools, or process improvement initiatives.

Responsibilities

Own US regulatory strategy for assigned products from concept through launch and lifecycle management.
Determine the appropriate US regulatory pathway and product classification, including OTC monograph drug, 510(k), De Novo, 510(k)-exempt device, cosmetic, or dietary supplement.
Assess products marketed in the UK/EU for the US market, identifying classification differences and needed changes to formulation, claims, labelling, or testing.
Lead regulatory feasibility and risk assessments and provide practical recommendations to the business.
Monitor and interpret US regulatory changes, including OTC monograph reform/OMUFA, MoCRA, and FDA QMSR, and assess their impact on the portfolio.
Prepare and own 510(k) submissions and Pre-Submissions, and respond to FDA requests for additional information.
Ensure OTC monograph compliance, including Drug Facts labelling and supporting documentation.
Manage establishment registrations and product listings for drugs and devices, and MoCRA cosmetic registration and listing.
Act as the point of contact for FDA correspondence and support FDA inspections with Quality.
Maintain complete, inspection-ready regulatory files and records.
Lead regulatory review and approval of labelling, packaging, claims, and promotional materials, including websites, social media, and retailer/e-commerce content, against FDA and FTC requirements.
Work with Marketing and Innovation to develop compliant, well-substantiated, commercially strong claims.
Provide early regulatory input to R&D and Innovation on new concepts and guide projects through the stage-gate process.
Advise Commercial, Marketing, Quality, and Customer Care, finding solutions that enable commercial opportunities.
Partner with Quality on complaints, adverse event reporting (device MDRs and OTC serious adverse events), and other post-market obligations.
Provide expert responses to regulatory enquiries from customers, retailers, distributors, and internal teams.
Lead regulatory workstreams on cross-functional projects, owning deliverables, timelines, and milestones.
Manage external partners such as consultants and test laboratories when needed.
Help improve regulatory processes and ways of working, including the use of digital and AI tools.