Temporary Contract - Regulatory Engineer

At ONWARD we're looking for a Temporary Contract - Regulatory Engineer to join our team until August 2025.

Full-time · Eindhoven / Lausanne

About the job

The Regulatory Engineer ensures the company’s medical devices meet established requirements and standards, manages regulatory filing in various markets and collaborates closely with cross-functional teams to prepare regulatory technical documentation.

Responsibilities

Manage registration of commercial products in different markets including US and OUS.
Maintain applicable standards list and traceability between technical documents and applicable standards.
Hands-on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations (worldwide). Maintain Technical files for submission (CE, FDA and more).
Perform routine regulatory monitoring, and coordinate with Subject matter experts the impact analysis of new/updated standards.
Perform regulatory impact analysis of design change requests and manage Letter to File process

About you

Master’s degree in biomedical engineering or equivalent, with a specialization in Regulatory.
3+ years of experience in Medical Device regulatory registrations. Experience with Active Devices is highly desirable.
Hands-on experience with the use of quality management system (ISO 13485), Risk management (ISO 14791), Biocompatibility ISO 10993 series and other horizontal standards such as ISO 62304, IEC 60601, ISO 62366, ISO 15223-1, …
Understanding of Regulatory processes in medical devices - Medical Device Regulation and FDA pathway.
Experience with EU MDR technical documentation preparation and FDA submission packages.
A high energy, fast-learner, self-motivated, pro-active personality able to work in a diverse team within a startup company; willing to help colleagues.
Fluent in English
Represents the ONWARD CODE (values).

Apply for the job

Do you want to join our team as our new Temporary Contract - Regulatory Engineer? Then we'd love to hear about you!

Apply now

OUR VISION Empowered by movement, people with spinal cord injury will enjoy life in every way that matters to them. We are a team of scientists, engineers and physicians, collectively driven to create therapies that change lives. We understand the challenges of those living with spinal cord injury. Formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL), we are now headquartered in Eindhoven, the Netherlands and within the city center in Lausanne, Switzerland. We also have a growing team in the USA.

Our website

Hiring with Homerun