• 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