Remote Senior US Regulatory Affairs Partner Eye Care

Scope Eyecare; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

Scope Eyecare is hiring a Regulatory Affairs Business Partner (Senior RA Specialist) to own US regulatory affairs for our eye care portfolio. You will determine pathways, lead 510(k) submissions, and guide labeling and promotional materials to ensure compliance.

You will work with cross-functional teams to bring UK/EU products to the US market, reporting to the Senior Regulatory Affairs Manager. Remote, US-based with occasional travel, eligible to work in the US.

Qualifications

• Hands‑on US regulatory affairs experience in OTC/consumer health products and/or medical devices.
• Direct experience with OTC monograph drug products and labeling requirements.
• Experience with US medical devices classification, establishment registration and listings.

Responsibilities

• Own US regulatory strategy from concept to launch and lifecycle management.
• Determine appropriate US pathway for each product (OTC monograph, 510(k), De Novo, etc.).
• Prepare and own 510(k) submissions and responses to FDA requests for information.
• Lead labeling reviews and promotional material approvals against FDA/FTC requirements.
• Collaborate with Quality, Commercial, Marketing and R&D to enable compliant product launches.

Skills

US regulatory affairs

OTC monograph

510(k) submissions

FDA/FTC labeling

Project leadership

Stakeholder mgmt

Education

Bachelor's degree Life Sciences

RAC (preferred)

Tools

Regulatory databases

SPL familiarity

Job description

Scope Eyecare is hiring a Regulatory Affairs Business Partner (Senior RA Specialist) to own US regulatory affairs for our eye care portfolio. You will determine pathways, lead 510(k) submissions, and guide labeling and promotional materials to ensure compliance.

You will work with cross-functional teams to bring UK/EU products to the US market, reporting to the Senior Regulatory Affairs Manager. Remote, US-based with occasional travel, eligible to work in the US.