Usa-regulatory affairs specialist ii (clinical)- remote - united states, cambridge bay
support the device regulatory lead in eu medical device regulation (mdr) article 117 related activities and change control assessments for combination products. provide assistance with filing preparations related to eu notified body opinions. perform maintenance activities related to change control assessments for combination products. support the the development of ways of working (wow) guides for the global regulatory affairs device role.
years of experience: 3 - 6 years. experience with combination products, medical device regulations, global device regulations, products that include: auto injectors, cross labeling, co packaging kits, and pre filled injected syringes. euro regulations experience a strong plus! position is 100% remote, no onsite training is required. must have industry experience in pharmaceutical industry, specific to device/drug experience.
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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