Grason-Stadler (GSI) was founded in 1949 as an audiologic equipment company; providing instrumentation for research and clinical measurement in the field of hearing. By 1952, GSI was recognized as a technology leader and introduced one of the first clinical audiometers to the market. To this day, GSI is recognized as a world leader in audiometric assessment instrumentation by serving hearing health professionals in over 70 countries. GSI offers a full line of audiometers, middle ear analyzers, otoacoustic emissions and auditory evoked potential instruments for all clinical, diagnostic and screening environments. Grason-Stadler’s mission is to set the standard in clinical audiology.
Responsible for managing all regulatory submissions and regulatory documentation to support compliance for GSI, as well as regulatory support assistance for all Diagnostic Group Companies. Responsible for helping to ensure regulatory requirements are implemented and maintained across all companies. Provide support for international registrations and support to global regulatory affairs teams when necessary.
Assist Research and Development in generation of the documentation needed for, but not limited to, safety, EMC, FDA, certification issues, and other regulatory requirements. From time to time, assist in project management of research and development projects at GSI.
Responsibilities and Duties:
Experience and or Education Requirements:
Physical Requirements (Include Travel): Occasional travel (domestic and international)
We are an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.