US - Regulatory Affairs Specialist

Title: Regulatory Affairs Specialist - Labeling - Junior

Location: Andover, MA

Shift: M-F, 8AM to 5pm

Duration: 12+ months

Job Description:

Role Overview -

include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc.

Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body. Maintains databases as required. Supports regulatory compliance projects as assigned.

Responsibilities -

Approximate the percentage of work associated with each responsibility.

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.

Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations. Trains to and

executes document management within local Product Lifecycle Management system and other electronic documentation systems as applicable. Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable

global regulatory requirements. Other activities as assigned.