Regulatory Specialist

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Requirements:

• Base knowledge of global regulatory requirements
• Project management skills a plus
• Demonstrated team collaboration
• Excellent communication, writing, and editing skills
• Strong Word, Excel, and PowerPoint skills

Responsibilities:

• Support frequent minor software releases by performing change assessments
• Support EU MDR application and maintenance of technical documentation, including clinical evaluation
• Collaborate with cross-functional teams to drive regulatory project management activities
• Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices
• Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors
• Gain experience with US FDA submissions
• Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
• Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
• Support Quality System management, as needed
• Other relevant duties as assigned
• Ability to work in a fast-paced adaptive environment, self-starter, and strong team player