Regulatory Affairs Manager

The Role

As the subject matter expert, you'll play a critical role in shaping the company's US market access strategy by providing specialist guidance across both FDA regulatory requirements and reimbursement planning.

Working closely with senior leadership and product development teams, you'll help ensure regulatory and commercial strategies are aligned to support successful market entry in the United States.

Key Responsibilities

• Develop and advise on FDA regulatory strategy for neuromodulation medical devices.
• Provide expert guidance on US reimbursement pathways, coding, coverage and payment strategies.
• Advise on FDA submission routes, including 510(k), De Novo and PMA where appropriate.
• Support regulatory planning throughout product development.
• Assess regulatory risks and recommend appropriate mitigation strategies.
• Develop reimbursement evidence strategies to support commercialisation.
• Advise on interactions with FDA and reimbursement stakeholders.
• Work alongside engineering, clinical and commercial teams to ensure regulatory and reimbursement considerations are incorporated into development plans.
• Monitor changes in FDA regulations and US reimbursement policies.

About You

You'll be a recognised expert in US regulatory affairs and reimbursement with extensive experience supporting innovative medical device companies.

Essential Experience

• Significant experience in FDA Regulatory Affairs for medical devices.
• Extensive knowledge of US reimbursement strategy, including coding, coverage and payment.
• Proven experience within the neuromodulation medical device sector.
• Strong understanding of FDA regulatory pathways including 510(k), De Novo and PMA.
• Experience developing reimbursement strategies that support successful US market access.
• Experience working with cross-functional clinical, engineering and commercial teams.
• Excellent stakeholder management and communication skills.
• Able to provide strategic advice while remaining hands-on when required.

Highly Desirable Experience

• Supporting early-stage or high-growth MedTech companies.
• Previous consulting or fractional leadership experience.
• Knowledge of CMS reimbursement processes.
• Experience with health economics and market access strategy.
• Familiarity with clinical evidence generation to support reimbursement.

Contract Details

Fractional Contract

Approximately 2–3 days per week

Fully Remote

Immediate Start Preferred

Competitive Day Rate