We are hiring for our client in medical device manufacturing domain.

Duration: 12 months (extendable)

Shift time: 8 AM - 5 PM

Description:

• 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 -

• 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 and executes document management within the local Product Lifecycle Management system and other electronic documentation systems as applicable.
• Updates and maintains product registrations with the US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.
• Other activities as assigned.

Job Types: Contract, Temporary

Pay: $38.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: In person