Job Description

• Provides administrative support for regulatory affairs manager
• Provides RA support for change control projects and sustaining activities
• Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)
• Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product team
• Responds to requests for product information by customers or other businesses
• bility to carry out the above tasks with minimal supervision
• Experience with disposable medical devices
• Experience with International registrations and renewal.

• Minimum Bachelor's degree; strongly preferred in science or engineering
• Minimum 1-3 years' experience in Regulatory Affairs in the medical device industry
• Demonstrated customer service, cross-functional collaboration, and teamwork skills
• Proven ability to manage multiple project deliverables and meet project timelines
• Effective written and verbal communication skills
• Scientific and analytical evaluation skills US FDA medical device regulations, standards, and guidance
• 21 CFR 820 - Quality System Regulation.

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