**Job Description:**

The **Regulatory Affairs Specialist II** creates, evaluates and completes regulatory tasks related to worldwide product registration submissions, facility registrations, special projects and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.

**This position is required to be on-site at least four days a week.**

**PRIMARY DUTIES & RESPONSIBILITIES:**

+ Assemble and maintain CE technical files in accordance with applicable regulatory requirements.
+ Author, review, and approve Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Periodic Safety ...