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We are Hiring!
We have an exciting new opportunity at Scope for a Regulatory Affairs Business Partner (Senior RA Specialist) to join our US team!
We are looking for people who can connect their own personal vision and values into some of what we do at Scope .
Our vision as a company is to become a leading force in Eyecare, with people at our core.
Please read below the full job description for the role and if this is something that you would be interested in, please click apply and a member of the Scope team will be in touch regarding your application.
Regulatory Affairs Business Partner (Senior RA Specialist)
SCOPE is an international, specialist eye care company, and our US business is growing fast. We are looking for an experienced regulatory professional to own US regulatory affairs for our eye care portfolio: 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 (Senior Regulatory Specialist level) for someone with US regulatory experience in OTC/consumer health and/or medical devices. You will be the go-to US regulatory expert in a small, close-knit team: setting regulatory strategy, making confident decisions on pathways, labelling and claims, and seeing products through from concept to launch and beyond.
You will work closely with Innovation, Product Development, Quality, Commercial, Marketing and Customer Care, and help bring products that are already successful in the UK and Europe to US patients and eye care professionals.
This role reports to the Senior Regulatory Affairs Manager.
Location: Remote, US-based, with occasional travel for team meetings and industry events. Candidates must be authorised to work in the US.
Key Responsibilities
US Regulatory Strategy & Ownership
Own the US regulatory strategy for assigned products from concept through launch and lifecycle management.
Determine the right US pathway and classification for each product (OTC monograph drug, 510(k), De Novo, 510(k)-exempt device, cosmetic or dietary supplement).
Assess products already marketed in the UK/EU (including CE-marked medical devices) for the US market, identifying classification differences and the changes needed to formulation, claims, labelling or testing.
Lead regulatory feasibility and risk assessments and give clear, practical recommendations to the business.
Monitor and interpret US regulatory changes (for example OTC monograph reform/OMUFA, MoCRA and FDA QMSR) and assess their impact on the portfolio.
Submissions, Registrations & Market Maintenance
Prepare and own 510(k) submissions, Pre-Submissions and responses 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, 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.
Labelling, Claims & Promotion
Lead the 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 build claims that are compliant, well substantiated and commercially strong.
Innovation & Business Partnering
Give early regulatory input to R&D and Innovation on new concepts and guide projects through the stage-gate process.
Act as a trusted advisor to 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 answers to regulatory enquiries from customers, retailers, distributors and internal teams.
Project Leadership
Lead the regulatory workstream on cross-functional projects end to end, owning deliverables, timelines and milestones.
Manage external partners where needed, such as consultants and test laboratories.
Help improve regulatory processes and ways of working, including the use of digital and AI tools.
Qualifications:
Required: Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, Engineering, Regulatory Affairs or a related discipline.
Desirable: RAC (Regulatory Affairs Certification) or equivalent.
Essential Knowledge, Skills and Experience
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.
A track record of independently leading regulatory projects from concept to launch.
Strong working knowledge of FDA and FTC labelling, advertising and claims requirements, and the confidence to give clear sign-off.
Experience managing correspondence with FDA.
Comfortable covering several product categories in a lean team and being the go-to regulatory person.
Excellent stakeholder management and communication skills, with the ability to influence commercial teams.
Desirable Experience
Ophthalmic products in the US market (for example lubricant eye drops, eyelid hygiene or other eye care products).
Sterile products, including ophthalmic sterility requirements.
Cosmetics (MoCRA) and dietary supplements (DSHEA, structure/function claims).
Bringing UK/EU products to the US market or working with an international regulatory team.
FDA QMSR / ISO 13485 quality systems.
Consumer health or FMCG environments, including retail and e-commerce channels.
Experience with AI, digital tools or process improvement initiatives.
Personal attributes
We're looking for someone who:
Makes confident, well-reasoned regulatory decisions and owns them.
Thinks creatively and finds practical routes to market rather than just identifying barriers.
Is collaborative, approachable and enjoys being part of a close-knit team.
Is driven and proactive, and enjoys a fast-paced, growing business.
Is motivated by making a meaningful impact through better eye care.
Scope provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Salary: $115k-$125k Originally posted on Himalayas