Regulatory & Compliance Manager

About Esper Bionics
 Esper Bionics is a human augmentation startup building advanced bionic limbs and digital health solutions. Our flagship product, the Esper Hand, helps people with limb differences live fuller, more empowered lives. We’re growing fast, driven by innovation, empathy, and a mission to bring futuristic healthcare to today’s world.

About the Role
 We are seeking a proactive and experienced Regulatory & Compliance Manager to lead and own all regulatory and compliance processes at Esper Bionics. You will be fully responsible for ensuring our medical devices meet international regulatory requirements, including managing submissions and registrations in the EU (MDR/EUDAMED) and US (FDA).

This role is a critical pillar in our growth strategy and will work cross-functionally with engineering, manufacturing, and clinical teams, as well as external consultants and authorities.

Key Responsibilities

• Lead and maintain the company’s Quality Management System (QMS) in compliance with ISO 13485.
  
  

• Own the preparation, submission, and maintenance of technical documentation and regulatory filings for FDA 510(k) and EU MDR / EUDAMED.
  
  

• Manage end-to-end certification, registration, and post-market surveillance processes in priority markets.
  
  

• Represent Esper Bionics in communications with regulatory bodies and notified bodies.
  
  

• Conduct internal audits, readiness checks, and risk assessments.
  
  

• Stay up-to-date with regulatory changes and implement them within internal processes.
  
  Collaborate with R&D, manufacturing, and clinical teams to ensure compliance is embedded into product lifecycle.
  
  

Candidate Requirements

• 3+ years of experience in regulatory affairs or quality assurance.
  
  

• Proven experience in regulatory submissions in the EU and US, including EUDAMED and FDA 510(k).
  
  

• Deep understanding of ISO 13485, MDR, FDA regulations, and related standards.
  
  

• Strong project management and cross-functional collaboration skills.
  
  

• Excellent written and spoken English (Upper-Intermediate+), especially in regulatory documentation.
  
  

• High attention to detail, analytical mindset, and ability to work independently in a fast-paced environment.
  
  

Preferred Qualifications

• Experience with digital health or software as a medical device (SaMD) is a strong plus.
  
  

• Background in biomedical engineering, quality systems, or related technical field.
  
  

• Experience working in startups or agile, innovation-driven environments.