Regulatory Affairs Engineer- On-Site- Scottsdale, AZ

Job Description

Job Description

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.

• Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product;
• Provides documentation and support for the submission / maintenance of regulatory documents for international regulatory bodies;
• Acts as the liaison between Innovative Health, the FDA and other international regulatory bodies;
• Reviews complaints / adverse events for submission of MDRs;
• Review and approve test protocols / reports and other documentation / information for regulatory submissions from various functional areas and check for errors, legibility, and missing information;
• Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects;
• Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities;
• Participates in internal / external audits and prepares responses to support audit findings or other respective actions related to such audits;
• Conduct regulatory review and approval of change orders, CAPA / nonconformance, and related project documentation;
• Review labeling and promotional material to ensure compliance with applicable regulations;
• Implement and maintain unique identifier (UDI) activities for implementation / compliance;
• Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards;
• Assists with DFMEA and PFMEA risk assessments;
• Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
• Develops and implements company policies and procedures;
• Assists in archiving regulatory documentation and maintaining related databases.

Qualifications :