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Medizinische/r Dokumentar/in

Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Hötting, Tirol, Österreich

External listingFull-time6 days ago

About The Role

Our Regulatory Affairs Department ensures that products comply with applicable regulations and standards. This includes providing strategic input for product development, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes affecting existing products and future product developments. Your Tasks Develop and implement a unified process to efficiently obtain and maintain global radio-frequency (RF) approvals Monitor and support alignment with EU and other key global environmental product compliance and lifecycle obligations for relevant products and processes Establish a process for regulatory intelligence monitoring for RF and environmental related regulatory changes relevant to the company Interpret and institute necessary change projects within regulatory and cross-department to ensure continued compliance on assigned topics Advise on required labeling or registration requirements to ensure and maintain market access Your Profile Bachelor's degree or higher in engineering, science, or a related field is required; familiarity with or experience in environmental regulations is preferred Knowledge of global RF regulatory requirements certification procedures including submission and testing needs, as well as basic technical understanding of radio equipment, radio testing or electronics design is desired Excellent spoken and written English is required, some German proficiency is an advantage Strategic and critical thinker, ability to see the big picture but keep a handle on the finer details Team player, highly motivated, attention to detail and dependable

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