Job Overview
The Principal Regulatory Affairs Specialist will be responsible for providing regulatory support to the product development process, submissions and compliance. This role requires strong communication skills to develop and maintain relationships with device reviewers.
Key Responsibilities
* Act as a company representative to develop and maintain positive relationships with device reviewers through oral and written communications.
* Develop and implement regulatory strategies for new and modified medical devices.
* Review and update EU regulatory documentation including technical documentation and post market surveillance deliverables such as SSCPs.
* Prepare FDA regulatory files such as pre-market approval (PMA's), supplements and amendments, 30-day notices, annual reports and 510ks.
* Review device labeling and advertising materials for compliance with global submissions and applicable regulations.
Requirements
* Bachelor's degree in STEM (Regulatory Affairs or relevant discipline).
Benefits of the Role
* This is an excellent opportunity to work in a dynamic team environment.
* The successful candidate will have the chance to develop their skills and knowledge in regulatory affairs.