Regulatory Specialist

At ONWARD we're looking for a Regulatory Specialist to join our team.

Full-time · Lausanne

About the job

The Regulatory specialist collaborates closely with the Development, Quality and Clinical teams for the preparation and submission of Regulatory Technical documentation (with focus on EU and US authorities).

Responsibilities

Hands-on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations (EU and US).
Maintain and update technical files to support submissions for market approval and clinical trials (EU and FDA).
Maintain applicable standards list and traceability between technical documents and applicable standards.
Manage Packaging and Labeling requirements.
Perform routine regulatory monitoring, and coordinate with Subject matter experts the impact analysis of new/updated standards
Perform regulatory impact analysis on design change requests.

About you

Masters’ degree in Biomedical Engineering or equivalent, with a specialization in Regulatory
3-5 years of experience in Medical Device regulatory. Experience with Active Implantable Devices is a plus.
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, ISO 14155 …
Understanding of Regulatory processes in Medical devices - Medical Device Regulation and FDA pathway
Experience with EU MDR technical documentation preparation and FDA submission packages.
Experience with Documentary requirements for clinical studies with medical devices.
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 and French.
Represents the ONWARD CODE (values): Empowered, Committed, Pragmatic, Innovative, Open, Trusting, Collaborative and Passionate

Apply for the job

Do you want to join our team as our new Regulatory Specialist? Then we'd love to hear about you!

Apply now

OUR VISION Empowered by movement, people with spinal cord injury will enjoy life in the way that matters to them. We are a team of scientists, engineers and narketers, 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 at the High Tech Campus in Eindhoven, the Netherlands and within the city center in Lausanne, Switzerland. We also have a growing team based in the USA.

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