RA/QA Specialist

Position Overview

Axiles Bionics is reinforcing its Market Access & Quality team, and we’re looking for a motivated and thoughtful RA/QA Specialist to join us as the first dedicated hire in this area.

You’ll work closely with our Chief Regulatory Officer to help shape and maintain a strong compliance framework that supports innovation and accelerates global market access of our prosthetic devices.

This isn’t just about documentation and procedures—we’re looking for someone who brings structure and critical thinking to the table, helping us build robust systems while staying agile and responsive in a fast-paced medtech environment.

What You’ll Do:

• You translate regulatory requirements into actionable strategies that guide product development, support commercialisation and ensure compliance throughout the product lifecycle.
• You prepare and maintain the technical documentation needed for market authorisation globally.
• You monitor evolving regulations and standards and help us stay ahead of the curve by proactively adapting processes.
• You collaborate cross-functionally—with engineering, clinical, marketing and operations teams—to integrate quality and regulatory compliance throughout the product lifecycle
• You participate in internal audits, external inspections, and interactions with authorities and other stakeholders.
• You contribute to the set up and ongoing improvement of our ISO 13485 Quality Management System.
• You bring clarity and precision to our documentation, and help us scale with quality in mind.
• You create and maintain quality and regulatory awareness within the company.

If you’re detail-driven, solutions-oriented, and eager to take on responsibility in a mission-driven startup, we’d love to hear from you. This is your chance to grow your regulatory and quality expertise while contributing directly to technologies that change lives.

Key Responsibilities

Regulatory Affairs

• Research regulatory requirements for medical and prosthetic devices in new target markets, engage with local stakeholders, perform gap analyses against existing Technical Documentation, and define action plans for compliance.
• Collaborate with the sales team to define product registration strategies in selected markets and manage registration processes in coordination with local partners and regulatory bodies.
• Support the creation of Technical Documentation during new product development in collaboration with the R&D and Clinical teams, to meet requirements for CE marking (MDR 2017/745), FDA submissions (21 CFR), and international registrations.
• Support the maintenance and regular updating of risk analyses in line with applicable standards (ISO 14971) and internal procedures.
• Develop and maintain product labeling materials (e.g. Instructions for Use, labels) in compliance with regulatory requirements.
• Ensure continued validity of market authorizations by keeping Technical Documentation complete, accurate, and up to date.
• Monitor changes in regulations and standards, identify gaps in current documentation and processes, and define action plans to ensure timely alignment and compliance.
• Coordinate post-market surveillance activities for existing prosthetic devices, including vigilance reporting, trend analysis, and periodic post-market surveillance reporting.
• Work with the marketing team to review promotional materials and ensure that product claims comply with national advertising regulations and relevant standards.
• Support and eventually take ownership of targeted regulatory projects (e.g. EUDAMED implementation, UDI requirements, etc.).

Quality Assurance

• Support the implementation and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485 and EU MDR requirements.
• Help establish and coordinate key quality processes, including non-conformity management, CAPA (Corrective and Preventive Actions), and change control.
• Oversee document control to ensure procedures, forms, and records are up to date, well organized, and accessible.
• Collaborate with the R&D team to support design control activities throughout the product development lifecycle.
• Manage customer complaints in coordination with the sales team, ensuring proper investigation, documentation, and follow-up.
• Perform device record reviews and product release activities, coordinating with the operations team to ensure compliance with quality and regulatory requirements.
• Work with relevant teams to define and implement missing processes. Draft, implement, and maintain procedures, work instructions, and related documentation as needed.
• Prepare for and actively participate in audits and inspections conducted by external parties (e.g. competent authorities).
• Collaborate with all departments to foster and maintain a strong culture of quality throughout the organization.

Profile

• Detail-oriented, analytical, and reliable in your follow-through.
• Strategic thinker with the ability to connect day-to-day tasks to broader goals.
• Flexible and proactive, with the ability to work independently in a fast-paced, innovative environment.
• Methodical and resilient—comfortable managing repetitive tasks while adapting to a dynamic regulatory landscape.
• Strong verbal and written communication skills, with the ability to interface effectively across functions.
• A collaborative team player with a hands-on attitude.
• Motivated to challenge the status-quo and build processes from the ground up.

Qualifications

• Master’s degree in (Biomedical) Engineering, Life Sciences, or a related field.
• 1–3 years of experience in regulatory affairs or quality assurance within a regulated industry (e.g., medical devices, pharmaceuticals, biotech, food). Experience in the medical device sector is a strong plus.
• Basic knowledge of the medical device regulatory landscape, including MDR 2017/745 and ISO 13485; familiarity with FDA regulations (21 CFR) is an asset.
• Proficiency in English, both written and spoken; additional languages are a plus.
• Bonus: Interest in or experience with robotics, prosthetics, or other bionic technologies.

Why join us?

You'll work across both regulatory and quality activities, gaining hands-on experience in medical device compliance—particularly in prosthetics. Over time, you’ll have the opportunity to grow in the direction that best matches your interests and strengths.

On top of that:

• Be part of a team revolutionizing prosthetics and transforming lives.
• Work in a dynamic, fast-growing startup rooted in world-class research.
• Enjoy flexible working hours and a collaborative, open-office culture.
• Competitive salary and excellent benefits.
• Join a mission-driven team that’s both supportive and ambitious.

Interview Process

• 30-minute on-line interview with the Chief Regulatory Officer.
• 60-minute in-person interview with the Chief Regulatory Officer.
• Final assessment of a practical case.

Interested?

Submit your CV and a motivation letter to: raqa_specialist@axilesbionics.odoo.com. We look forward to hearing from you!