Kanton Appenzell Innerrhoden
Appenzell Steinegg
Regulatory Affairs Specialist 80-100 %
- 18 July 2026
- 80 – 100%
- Permanent position
- Appenzell Steinegg
Job summary
Die Wyon AG ist ein führendes Unternehmen im Bereich Lithium-Ionen-Batterien. Hier hast du die Chance, innovative Medizintechnik zu gestalten.
Tasks
- Sicherstellung der Einhaltung interner Produktdokumentation.
- Mitwirkung an Risikoanalysen nach ISO 14971.
- Leitung von Ursachenanalysen bei Kundenreklamationen.
Skills
- Langjährige Erfahrung mit regulatorischen Anforderungen für Implantate.
- Gute Kenntnisse von ISO 13485 und ISO 14971.
- Sichere Deutsch- und Englischkenntnisse in Wort und Schrift.
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About the job
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
