Regulatory Affairs Specialist – Medizintechnik (m/w/d)
Core
Create and maintain technical documentation and regulatory files for medical devices, ensuring compliance across the product lifecycle.
Role type
Regulatory Affairs Specialist (Technical Documentation)
Builds
Medical device regulatory submissions and technical documentation
Domain
Medical Technology / Regulatory Compliance
Required skills
Technical or natural science degree, Medical Device Regulation knowledge, Technical Documentation expertise, DIN EN ISO 13485 knowledge, MS Office proficiency, ERP system usage, German (C1), English (C1)
Preferred skills
Experience in Regulatory Affairs for medical device companies
Responsibilities
Plan, create, and update technical documentation; manage risk management for medical devices; prepare and coordinate applications and change notifications for notified bodies and authorities; serve as a central contact for regulatory questions
Seniority
Entry-level to Mid-level