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