Senior Regulatory Affairs Engineer - Remote

Overview

Neko Health is seeking a Senior Regulatory Affairs Engineer who is passionate about tackling complex regulatory strategies and enjoys working with cutting-edge medical devices in a fast-paced, collaborative environment.

In Short

• Drive regulatory excellence to ensure compliance with global standards.
• Support product development by advising on regulatory strategy.
• Maintain regulatory documentation such as Design History File and Device Master Record.
• Prepare and submit documentation for EU MDR and FDA.
• Participate in post-market surveillance and complaint management.
• Coordinate communications with regulatory bodies.
• Guide teams to integrate regulatory requirements into the Quality Management System.
• Monitor regulatory trends to keep the company compliant.

Requirements

• BSc or MSc in law, medicine, pharmacy, engineering, or related field.
• 4–5+ years in regulatory affairs for active medical devices.
• Deep knowledge of EU MDR, FDA CFR, UK MDR, and ISO standards.
• Analytical and detail-oriented with strong interpretation skills.
• Excellent interpersonal and writing skills.
• Self-motivated and ready to take ownership in a dynamic environment.
• Fluent in English; Swedish proficiency is a plus.

Benefits

• Opportunity to work with cutting-edge medical technology.
• Collaborative and dynamic work environment.
• Impactful role in shaping regulatory strategies.
• Professional development and training opportunities.