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1 Vacancy
Perform the following functions under general supervision:
Support premarket and postmarket activities
Assist in creation compilation and management of regulatory submissions
Obtain document notarization apostillization legalization as needed
Serve as point of contact for International Affiliates and dealers regarding registration activities
Responsible for archiving and maintaining regulatory documents
Escalate issues and questions as needed
Train and adhere to regulatory processes
Perform other tasks as assigned
Bachelors degree; degree in a scientific discipline a plus
Two years of work experience. Experience in a regulated industry orexperience in regulatory affairs (medical devices) a plus
Experience in a fastpaced multitasking customerfacing environment with deadlines that required strong attentiontodetail and positive outcomes
Experience encountering ambiguous situations and determining when to escalate to management
Strong verbal and written communication and interpersonal skills
Strong time management and organizational skills
Strong computer skills including MS Office
Knowledge of US EU and international medical device regulations a plus
Certified Notary a plus
Required Experience:
IC
Full-Time