Regulatory Affairs Specialist 80-100 %

Your tasks:

• You ensure that the internal product documentation complies with regulatory and internal requirements and is adjusted if necessary
• You participate in product- and process-related risk analyses according to ISO 14971
• You provide regulatory advice for our Medtech customers
• You take over the management of root cause analysis for customer complaints as well as the initiation of CAPA measures and their documentation (8D)
• You are the contact person for customer audits for all regulatory questions

Wyon AG develops and produces customised lithium-ion batteries in small and micro sizes for medical applications with 200 employees today. Through patented and highly innovative technologies, we are often one step ahead of the industry; Wyon AG is now the world market leader in the manufacture of rechargeable batteries for cochlear implants.