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.
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: firstname.lastname@example.org
Life Sciences Recruitment Specialist
Team Leader & Recruitment Management Life Sciences