Regulatory Affairs Specialist 80-100 %

• 18 July 2026
• 80 - 100%
• Permanent position
• Appenzell Steinegg

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.
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

Your skills:

• You bring many years of experience in regulatory requirements along the product lifecycle, especially for implants
• You have experience in how component documentation flows into an MDR Class III / FDA PMA approval
• You have good knowledge of standards ISO 13485, have a technical basic understanding of ISO 14971 and apply ISO 14971 for medical devices or their components
• You have a confident handling of EU MDR (EU 2017/745) and have knowledge of international requirements (e.g. FDA, MDSAP advantageous)
• You bring a high level of quality awareness and personal responsibility
• Your working method is reliable, structured, analytical and clean
• You have a pronounced entrepreneurial mindset
• You have very good German and English skills, both spoken and written