Regulatory affairs associate Jobs in Phoenix, AZ

Job Description

Job Description

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for pre-market submissions (i.e., FDA 510(k) submissions, Health Canada Medical Device License Applications) and documentation for other international regulatory bodies. This role also supports post-market regulatory compliance activities.

Essential Duties and Responsibilities :

• Write and lead the completion of high quality pre-market submissions;
• Review and verify documents / technical information for regulatory submissions from various functional areas and check for errors, legibility, and missing information;
• Review and approve protocols and reports to support regulatory submissions;
• Prepare or assist with preparation of additional information or responses as requested by regulatory agencies;
• 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;
• 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;
• 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 and policies;
• Implement and maintain unique identifier (UDI) activities for compliance;
• Assist with PFMEA risk assessments;
• Review complaints / adverse events for assessment of reportability and submission of MDRs if appropriate;
• Assist in archiving regulatory documentation and maintaining related databases;
• Participate in internal and external audits;
• Write or update standard operating procedures, work instructions or policies;
• Assist with coordinating recall or market withdrawal activities as necessary;
• Other duties as assigned.

Supervisory Responsibilities :

None

Education, Qualifications and Skills :

Work Environment :