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

• Reviews 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 will 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.
• Researches and authors regulatory assessments and strategies for client products. This will include identifying the anticipated regulatory classification and suggesting analytical and clinical testing requirements.
• Attends meetings with regulatory agencies to capture meeting minutes and feedback from agency review team.
• Performs regulatory document management for clients.
• Maintains general oversight of timelines, budgets, and scope of work for client deliverables and FDA submissions. 
• Contributes to subject matter content for blog posts and articles and supports Business Development efforts, including conference, webinar, or information session presentation, as needed.
• Authors and revises standard operating procedures (SOPs), forms, work instructions, templates, and plans for compliance with regulatory and quality requirements.
• Contributes to the training and implementation of SOPs, including the generation of training materials.
• Performs quality document management for client projects, including gaining proficiency in using client’s quality management system (QMS) software.
• Contributes to and conducts client internal audits and supplier evaluations and audits as well as assists with CAPAs.
• Effectively communicates regulatory requirements and strategies to internal team and external clients.
• Works 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.
• Tracks outstanding agency issues and ensure/coordinate appropriate follow-up on action items.
• Develops and maintains knowledge and understanding of FDA regulations, guidelines, international harmonization documentation, and existing/approved products to assist with making recommendations for individual projects.
• May delegate, review, and manage work of Regulatory Associates as necessary to meet client and company timelines.

• 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.
• Must have 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.).