Regulatory Affairs and Quality Assurance Specialist

About the Role

Assist with regulatory research to support investigational products in seeking regulatory clearance or approval. Prepare and review regulatory submissions, maintain Regulatory Chronological Files, anticipate and plan for future client regulatory and quality needs, and perform other duties relating to Proxima support of client regulatory and quality needs with minimal supervision.

Responsibilities

• Review client materials to author high-quality regulatory submissions to the FDA and other regulatory agencies within client and company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include:
  • Q-Submission Requests
  • 510(k) Submissions
  • De Novo Classification Requests
  • Premarket Approval Applications
  • CE Mark
  • IDE and IND Applications
  • ANDAs
  • Amendments
  • Supplements
  • Annual Reports
  • 505(b)(2) and 505(b)(1) submissions
• Research and author regulatory assessments and strategies for client products, including identifying the anticipated regulatory classification and suggesting analytical and clinical testing requirements.
• Attend meetings with regulatory agencies to capture meeting minutes and feedback from the agency review team.
• Perform regulatory document management for clients.
• Maintain general oversight of timelines, budgets, and scope of work for client deliverables and FDA submissions.
• Contribute to subject matter content for blog posts and articles and support Business Development efforts, including conference, webinar, or information session presentations, as needed.
• Author and revise standard operating procedures (SOPs), forms, work instructions, templates, and plans for compliance with regulatory and quality requirements.
• Contribute to the training and implementation of SOPs, including the generation of training materials.
• Perform quality document management for client projects, including gaining proficiency in using client’s quality management system (QMS) software.
• Contribute to and conduct client internal audits and supplier evaluations and audits, as well as assist with CAPAs.
• Effectively communicate regulatory requirements and strategies to internal teams and external clients.
• Work on complex projects to solve problems where analysis of the situation or data requires multiple perspectives and sound interpretation of regulatory requirements and/or guidelines.
• Track outstanding agency issues and ensure/coordinate appropriate follow-up on action items.
• Develop and maintain knowledge and understanding of FDA regulations, guidelines, international harmonization documentation, and existing/approved products to assist with making recommendations for individual projects.
• Delegate, review, and manage the work of Regulatory Associates as necessary to meet client and company timelines.

Requirements

• Bachelor’s Degree or equivalent.
• Minimum of 2 years of experience in Regulatory Affairs in the areas of medical devices, drugs, and biologics or otherwise established proficiency as determined by management.
• Basic knowledge of federal regulations (21 CFR) pertaining to devices, drugs, product approval and listing information, and regulatory maintenance activities (Annual Reports, FDA inspections, etc.).