Senior Regulatory Affairs Business Partner

🕒 August 4

🇺🇸 United States – Remote

💵 $115k - $125k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

SCOPE Eyecare & Healthcare

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🍽️ Food & Beverage

🏭 Manufacturing

🏥 Healthcare

Food & Beverage • Manufacturing • Healthcare

SCOPE Eyecare & Healthcare is a company that specializes in providing a range of eye care products, particularly aimed at managing ocular surface diseases. They offer a variety of preservative-free ocular lubricants under brands such as HYLO, Hycosan, and OPTASE, targeting severe dry eye disease, MGD, and Blepharitis. Their product line includes eye drops, eyelid wipes, and dietary supplements to support eye health. With a presence in Ireland and the UK, SCOPE Eyecare & Healthcare supports clinicians and patients by offering high-quality eye care solutions and conducting seminars on well-being related to dry eye conditions.

📋 Description

• Own US regulatory strategy for assigned products from concept through launch and lifecycle management • Determine US regulatory pathways and classifications, including OTC monograph drugs, 510(k), De Novo, 510(k)-exempt devices, cosmetics and dietary supplements • Assess UK/EU products for the US market and identify required formulation, claims, labelling and testing changes • Lead regulatory feasibility and risk assessments and provide practical recommendations • Monitor and interpret US regulatory changes, including OTC monograph reform/OMUFA, MoCRA and FDA QMSR • Prepare and own 510(k) submissions, Pre-Submissions and responses to FDA information requests • Ensure OTC monograph compliance, including Drug Facts labelling and supporting documentation • Manage establishment registrations and product listings for drugs, devices and cosmetics • Act as FDA correspondence contact and support FDA inspections with Quality • Maintain complete, inspection-ready regulatory files and records • Review and approve labelling, packaging, claims and promotional materials across websites, social media and retailer/e-commerce content • Provide regulatory input to R&D and Innovation and guide projects through stage-gate processes • Advise Commercial, Marketing, Quality and Customer Care on regulatory solutions • Partner with Quality on complaints, adverse event reporting and post-market obligations • Respond to regulatory enquiries from customers, retailers, distributors and internal teams • Lead regulatory workstreams on cross-functional projects and own deliverables, timelines and milestones • Manage external partners such as consultants and test laboratories • Improve regulatory processes and ways of working, including digital and AI tools

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, Engineering, Regulatory Affairs or a related discipline • Candidates must be authorised to work in the US • 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 • Experience managing correspondence with FDA • Comfortable covering several product categories in a lean team • Excellent stakeholder management and communication skills • Desirable: RAC (Regulatory Affairs Certification) or equivalent • Desirable experience with ophthalmic products, sterile products, cosmetics (MoCRA), dietary supplements (DSHEA), UK/EU-to-US product launches, FDA QMSR/ISO 13485, consumer health/FMCG, retail and e-commerce channels, AI, digital tools or process improvement initiatives

🏖️ Benefits

• Remote work arrangement • Occasional travel for team meetings and industry events • Equal employment opportunities and protection from discrimination and harassment