RA reviewer - Submitter

Job Title: Regulatory Content Reviewer – Medical Devices
Location: Remote, with preferred locations in Egypt (Cairo), Turkey (Istanbul, Ankara), South Africa (Johannesburg), Romania, and Hungary
Contract Duration: 1 year
Type: Full Time

About the Role:
We are looking for a highly analytical, detail-oriented professional to join our team as a Regulatory Content Reviewer for medical devices. You will be responsible for assessing promotional materials, labeling, and claims to ensure compliance with regulatory and policy frameworks, including EU MDR and FDA regulations. This role is critical in supporting business acceleration while maintaining high standards of quality and compliance.

Key Responsibilities:

• Assess content for compliance with EU Medical Device Regulation (MDR) and FDA regulations, including promotional materials, labeling, and claims.

• Apply a risk-based approach to review and approve submissions, ensuring documentation meets regulatory standards.

• Lead review meetings independently, structure discussions, align stakeholders, and document outcomes & next steps.

• Provide clear, practical guidance to cross-functional teams, translating regulatory requirements for business stakeholders.

• Propose compliant solutions and alternatives to support business objectives and acceleration.

• Manage multiple submissions/reviews in parallel, consistently meet tight deadlines, and maintain high-quality standards.

• Collaborate effectively with global and cross-functional partners including Marketing, Legal, Regulatory, and Compliance teams.

Key Skills & Experience:

• Strong analytical and critical thinking skills.

• Solid legal and regulatory understanding of EU Medical Device Regulation (MDR); experience with FDA regulations highly desirable.

• Experience working in highly regulated environments such as healthcare, pharma, or medical devices.

• High attention to detail and strong documentation standards.

• Highly organized; capable of managing multiple priorities.

• Solution-oriented and pragmatic mindset.

• Clear, professional written communication skills.

• Comfortable working with stakeholders across multiple functions and geographies.

Ready to drive compliance and solutions in the medical device industry? Apply today!