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Regulatory Affairs Business Partner – US Markets
SCOPE Eyecare & HealthcareRegulatory Affairs Business Partner supporting US FDA compliance for Scope’s eyecare portfolio. Guiding medical device, OTC, cosmetic, supplement and pharmaceutical products from ideation through lifecycle management.
Posted 8/4/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $115,000 - $125,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in US regulatory activities, including FDA submissions and compliance for medical devices and OTC medicines, while effectively collaborating with cross-functional teams throughout the product lifecycle.
Highest-signal resume keywords
US Regulatory ActivitiesFDA RequirementsRegulatory SubmissionsStakeholder ManagementProduct Lifecycle Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory GuidanceRegulatory StrategyRisk EvaluationsProduct Claims ReviewLabelling ComplianceStage-Gate Process510(k) SubmissionsNDA ActivitiesOphthalmic ProductsSterile Products
Soft Skills
Communication SkillsOwnershipCollaborationProactive ApproachRelationship-Focused
Tools & Technologies
Digital ToolsProcess Improvement Initiatives
Industry Keywords
Medical DevicesOTC MedicinesLicensed MedicinesPharmaceutical ProductsCosmeticsFood SupplementsInternational Regulatory Environments
About the role
Key responsibilities & impact- Provide regulatory guidance and support for the US market
- Assess regulatory requirements and pathways for new and existing products
- Support regulatory strategy throughout the product lifecycle
- Review product claims, labelling and promotional materials
- Monitor and interpret regulatory requirements, guidance and industry developments
- Support regulatory assessments and risk evaluations
- Partner with R&D and Ideation teams on new product concepts
- Support product development projects through the stage-gate process
- Provide regulatory guidance through development and commercialisation
- Act as a trusted partner to Product Development, Commercial, Marketing, Customer Care and Quality teams
- Participate in cross-functional project teams and decision-making
- Respond to regulatory enquiries and customer-facing information requests
- Lead regulatory activities for assigned projects and coordinate deliverables and timelines
- Support FDA submissions, registrations, market maintenance, FDA interactions and correspondence
- Maintain regulatory records and documentation
Requirements
What you’ll need- Experience supporting US regulatory activities
- Hands-on experience working with FDA requirements
- Experience supporting medical devices and/or OTC medicines
- Experience preparing, reviewing or supporting regulatory submissions
- Strong understanding of US labelling, claims and compliance requirements
- Experience supporting products throughout the product lifecycle
- Strong stakeholder management and communication skills
- Ability to work independently and take ownership of projects
- Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs or a related discipline
- Desirable: experience with 510(k) submissions
- Desirable: experience interacting directly with FDA
- Desirable: experience with licensed medicines or pharmaceutical products
- Desirable: exposure to NDA or post-approval pharmaceutical activities
- Desirable: experience supporting ophthalmic products in the US market
- Desirable: experience with cosmetics and food supplements
- Desirable: experience with sterile products
- Desirable: experience supporting innovation and stage-gate product development processes
- Desirable: experience working within international regulatory environments
- Desirable: experience with AI, digital tools or process improvement initiatives
- Collaborative, proactive, creative, authentic and relationship-focused approach
- Ability to work in a fast-paced and evolving environment
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account SCOPE Eyecare & Healthcare Website LinkedIn All 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. Regulatory Affairs Business Partner – US Markets Job not on LinkedIn 🔥 8 minutes ago 🇺🇸 United States – Remote 💵 $115k - $125k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Provide regulatory guidance and support for the US market
- Assess regulatory requirements and pathways for new and existing products
- Support regulatory strategy throughout the product lifecycle
- Review product claims, labelling and promotional materials
- Monitor and interpret regulatory requirements, guidance and industry developments
- Support regulatory assessments and risk evaluations
- Partner with R&D and Ideation teams on new product concepts
- Support product development projects through the stage-gate process
- Provide regulatory guidance through development and commercialisation
- Act as a trusted partner to Product Development, Commercial, Marketing, Customer Care and Quality teams
- Participate in cross-functional project teams and decision-making
- Respond to regulatory enquiries and customer-facing information requests
- Lead regulatory activities for assigned projects and coordinate deliverables and timelines
- Support FDA submissions, registrations, market maintenance, FDA interactions and correspondence
- Maintain regulatory records and documentation 🎯 Requirements
- Experience supporting US regulatory activities
- Hands-on experience working with FDA requirements
- Experience supporting medical devices and/or OTC medicines
- Experience preparing, reviewing or supporting regulatory submissions
- Strong understanding of US labelling, claims and compliance requirements
- Experience supporting products throughout the product lifecycle
- Strong stakeholder management and communication skills
- Ability to work independently and take ownership of projects
- Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs or a related discipline
- Desirable: experience with 510(k) submissions
- Desirable: experience interacting directly with FDA
- Desirable: experience with licensed medicines or pharmaceutical products
- Desirable: exposure to NDA or post-approval pharmaceutical activities
- Desirable: experience supporting ophthalmic products in the US market
- Desirable: experience with cosmetics and food supplements
- Desirable: experience with sterile products
- Desirable: experience supporting innovation and stage-gate product development processes
- Desirable: experience working within international regulatory environments
- Desirable: experience with AI, digital tools or process improvement initiatives
- Collaborative, proactive, creative, authentic and relationship-focused approach
- Ability to work in a fast-paced and evolving environment Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Country Trade Compliance Officer 🔥 51 minutes ago Hitachi 10,000+ employees 🚘 Automotive 🏗️ Construction 💼 Consulting Website LinkedIn All Job Openings Hitachi Energy trade compliance manager overseeing U.S. import, export, customs, and sanctions requirements. Advising global power-industry teams and strengthening regulated supply-chain processes. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🔴 Lead 🚔 Compliance 🦅 H1B Visa Sponsor Complaints Compliance Analyst 🔥 55 minutes ago Coastal 201 - 500 🏦 Banking 💳 Fintech 🤝 B2B Website LinkedIn All Job Openings Complaints Compliance Analyst reviewing complex regulatory and customer complaints for Coastal’s modern banking and fintech operations. Ensuring timely, compliant resolutions and mitigating regulatory risk. 🇺🇸 United States – Remote 💵 $77.5k - $83k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Associate Director, Information Governance, Data Compliance 🔥 1 hour ago S&P Global 10,000+ employees 💼 Consulting 📦 Logistics 📣 Marketing Website LinkedIn All Job Openings Information governance leader strengthening data compliance and AI oversight at S&P Global. Designing enterprise policies, controls, classification frameworks, and responsible AI governance for global data products. 🇺🇸 United States – Remote 💵 $104.4k - $182.6k / year ⏰ Full Time 🟠 Senior 🚔 Compliance GRC Analyst 🔥 1 hour ago US Anesthesia Partners 5001 - 10000 💼 Consulting 🏥 Healthcare ⚕️ Healthcare Insurance Website LinkedIn All Job Openings GRC Analyst strengthening USAP’s healthcare security governance and compliance program. Managing controls, risk assessments, audits, policies, and third-party vendor risk. 🇺🇸 United States – Remote 💵 $80.9k - $137.6k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance US Regulatory Strategy Lead 🔥 2 hours ago Sobi - Swedish Orphan Biovitrum AB (publ) 1001 - 5000 🏥 Healthcare 🧬 Biotechnology 💊 Pharmaceuticals Website LinkedIn All Job Openings US Regulatory Strategy Lead advancing FDA strategy for Sobi’s rare-disease therapies. Leading regulatory pathways, health authority interactions, submissions, and labeling for development and marketed products. 🇺🇸 United States – Remote 💵 $185k - $210k / year ⏰ Full Time 🟠 Senior 🚔 Compliance View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs