Regulatory Affairs Business Partner – US Markets

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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

• 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