Job Summary:

• 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.

Job 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.