Regulatory Affairs

Job Title:Regulatory Affairs

Job Description

The Senior Regulatory Affairs Associate will support the definition of the regulatory strategy for Lumin Innovations Diagnostic Medical Displays. This position will play a substantial role in researching regulations, defining, and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. The successful candidate should possess a scientific background and will understand electromechanical devices. The ability to deal with ambiguity and think outside the box is critical for this position.

Responsibilities

• Regulatory lead/representative on project core teams providing regulatory input on all matters.
• Leads preparation, documentation and submission of FDA and other international applications and providing responses to regulatory agencies regarding medical displays information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes.
• Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings.
• Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA and other country-specific regulations as required.
• Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.
• Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.
• Assesses product, manufacturing and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance to regulations.
• Reviews technical reports for incorporation into regulatory submissions.
• Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced.
• Maintain current knowledge of relevant regulations and guidelines, both proposed and final rules.
• Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
• Support post-approval products through change evaluation and submission.
  
  

Qualifications

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