For one of our client; an innovative and fast-growing niche medical device company specialised in Neurosciences, we are currently looking for a Clinical and Regulatory Affairs Manager to manage the Regulatory and Clinical Affairs activities at international level.
Develop, prepare and manage all specific documentation and processes for clinical studies and regulatory submissions.
Set up and monitor clinical studies with various stakeholders and prepare clinical documentation to support clinical studies.
Control clinical trial documentation in accordance with the clinical investigation plan and ISO 14155.
Provide regulatory and clinical support for risk management throughout the product life cycle.
Provide post-market surveillance and regulatory monitoring.
Represent Regulatory and Clinical Affairs on the project team for new product development in the field of neurotechnology, neuroimaging and neurobiology.
Maintain the Center's key relationships with the relevant regulatory authorities and Key Opinion Leaders (KOLs)/Advisors.
MS in Biomedical Engineering or Life Sciences, with minimum 7-10 years of experience in Regulatory Affairs and Clinical Studies for medical devices (preferably with Class III medical devices).
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)…