Regulatory affairs manager Jobs in Scottsdale, AZ

Job Description

Job Description

The Regulatory Affairs Specialist 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 :