Regulatory Affairs Business Partner – US Markets

We are Hiring!

We have an exciting new opportunity at Scope for a Regulatory Affairs Business Partner (US Markets) 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 - US Markets

We are looking for an experienced Regulatory Affairs Business Partner to support our growing US business and act as a key regulatory partner across the organisation.

This is a highly collaborative role, working closely with Innovation, Product Development, Quality, Commercial, Marketing and Customer Care teams to bring new products to market and maintain compliance across existing portfolios.

You will provide regulatory support from product ideation through development, commercialisation and lifecycle management, helping to ensure products are compliant, commercially viable and aligned with business objectives.

The role will support a diverse portfolio including medical devices, OTC medicines, cosmetics, food supplements and pharmaceutical products.

The Regulatory Affairs Business Partner will be reporting to the Senior Regulatory Affairs Manager.

This is a Remote role with occasional travel for team meetings.

Key Responsibilities

Regulatory Strategy & Compliance

• Provide regulatory guidance and support for the US market.
• Assess regulatory requirements and pathways for new and existing products.
• Support regulatory strategy development throughout the product lifecycle.
• Review product claims, labelling and promotional materials.
• Monitor and interpret relevant regulatory requirements, guidance and industry developments.
• Support regulatory assessments and solution driven risk evaluations.

Innovation & Product Development

• Partner with the R&D and Ideation teams to provide early regulatory input on new product concepts.
• Assess regulatory feasibility and identify potential opportunities and barriers.
• Support product development projects through the stage-gate process.
• Contribute to claims development and product positioning discussions.
• Provide regulatory guidance throughout development and commercialisation.

Business Partnering

• Act as a trusted regulatory partner to Product Development, Commercial, Marketing, Customer Care and Quality teams.
• Participate in cross-functional project teams and decision-making.
• Enable commercial opportunities through solution-focused regulatory support and clear, practical recommendations.

Customer Care & Commercial Support

• Respond to regulatory enquiries from Customer Care, Sales and commercial teams.
• Support customer-facing regulatory information requests.
• Assist with product-related compliance questions and investigations.

Project Ownership

• Lead regulatory activities for assigned projects.
• Coordinate regulatory deliverables and timelines.
• Drive projects forward and ensure regulatory milestones are achieved.

Regulatory Submissions & Market Maintenance

• Support FDA submissions, registrations and market maintenance activities as required.
• Contribute to regulatory strategies relating to FDA pathways, including 510(k) and NDA submissions where applicable.
• Support FDA interactions and correspondence where required.
• Maintain regulatory records and documentation.

Specific Knowledge, Skills and Experience

Required Experience:

• 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.

Desirable Experience

• Experience with 510(k) submissions.
• Experience interacting directly with FDA.
• Experience with licensed medicines or pharmaceutical products.
• Exposure to NDA or post-approval pharmaceutical activities.
• Experience supporting ophthalmic products in the US market.
• Experience with cosmetics and food supplements.
• Experience with sterile products.
• Experience supporting innovation and stage-gate product development processes.
• Experience working within international regulatory environments.
• Experience with AI, digital tools or process improvement initiatives.

Qualifications:

Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs or a related discipline.

Personal attributes

We're looking for someone who:

• Is collaborative and enjoys working as part of a close-knit team.
• Is driven and proactive, taking ownership and delivering results.
• Thinks creatively and can find practical regulatory solutions.
• Is authentic, approachable and relationship-focused.
• Enjoys working in a fast-paced and evolving environment.
• Brings positive energy and contributes to a supportive team culture.
• Understands that what we do matters and 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.

Compensation: $115k-$125k