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