RA Associate

1 month ago


Dublin, United States DBA: Zeiss Group Full time

* 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



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