Regulatory & Clinical Affairs Engineer

  • Geneva
  • Posted: Sep 24, 2021

We are currently looking for a Regulatory & Clinical Affairs Engineer to write all the technical documentation to be submitted to the international regulatory authorities for clinical studies and/or CE marking, for the development of new class III active implantable Medical Devices. Join an independent, innovative and fast-growing company for the research and development of Medical Devices in neurosciences.

Responsabilities :

  • Write and manage all technical documentation for Medical Devices and carry out pre-submissions and regulatory submissions internationally to facilitate future marketing approvals (obtaining CE marking, PMA, FDA 510K...).
  • Define the regulatory strategy and ensure interactions with the various notified bodies and authorities (FDA, Swissmedic, etc.)
  • Actively participate in scientific and regulatory projects and discussions with all departments as part of the regulatory and clinical strategy.
  • Support risk management activities throughout the product life cycle from a regulatory perspective.
  • Participate in clinical investigation and evaluation alongside the clinical, quality and regulatory department.
  • Ensure the regulatory monitoring of Medical Devices.

Your Profile :

  • MS in Biomedical Engineering or Life Sciences, with minimum 6 years of experience in Regulatory Affairs for medical devices (preferably with Class III medical devices).
  • Experience in pre-submission of clinical evaluation for Medical Devices is required
  • Proficiency in medical device regulations including ISO 13485, MDR 2017/745/EU and 21 CFR Part 820 for FDA.
  • Experience and/or knowledge of at least one of these areas/regulations: clinical investigations (GCP and ISO 14155), electrical or active implantable medical devices (ISO 14708 / IEC 62366-1 / IEC 60601 / IEC 62304…), biological evaluation for medical devices (ISO 10993-1)…
  • Fluency in English ; French is an asset.

For more information, please contact : Morgane CAYUELA: mc@axepta.com

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Regulatory & Clinical Affairs Engineer

Sep 24, 2021Regulatory & Clinical Affairs EngineerGeneva Permanent Job mc@axepta.com Life Sciences

Apply For This AD

Maximum file size: 300 MB.

Allowed Type(s): .pdf, .doc, .docx

Maximum file size: 300 MB.

Allowed Type(s): .pdf, .doc, .docx

To revoke my consent or obtain more information, we invite you to contact Axepta SA directly.