RA Associate
·Perform the following functions under general supervision:
·Support pre-market and post-market 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
·Bachelor’s 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 fast-paced, multi-tasking, customer-facing environment with deadlines that required strong attention-to-detail 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