Regulatory Affairs Specialist

Axogen is hiring a Regulatory Affairs Specialist in Alachua or Tampa, FL!

Job Summary of the Regulatory Affairs Specialist

The Regulatory Affairs Specialist will assist the Regulatory Affairs Leads and broader organization in navigating regulatory approval procedures and management of regulated information as part of the Regulatory Affairs Strategic and Centralized Services team. The specialist is a crucial link between the Regulatory Affairs Centralized Services team, Regulatory Affairs Product Leads, Axogen Regulatory data and information management systems, and legal and business functions across the organization.  

Requirements of the Regulatory Affairs Specialist

• A degree or certification-level qualification in a relevant life sciences discipline (i.e. an Associate Degree or 1-3 years’ work experience) in in healthcare, research, or another science-related field.
• Must be detailed oriented and highly organized with the ability to prioritize and organize projects to meet deadlines, while being flexible to unexpected priority requests • Must have strong verbal, written, and interpersonal communication skills.
• Excellent judgment, problem-solving abilities, and the ability to work in a team environment
• Experience with a multi-location office setting with core contributors to the work product in remote or virtual settings
• Must respect the confidential nature of the work and information held in Regulatory Affairs
• Proactive and action-oriented, able to accept and act upon directions within the Regulatory Affairs matrix
• Must have the ability and desire to learn new software and procedures quickly
• Strong technological aptitude
• Medical or Industry terminology knowledge is a benefit but not required 

Responsibilities of the Regulatory Affairs Specialist

The regulatory affairs specialist will assist in the coordination and organization of multiple facets of regulatory procedures and operations within the Regulatory Affairs service function and across the Axogen product portfolio including but not limited to:

• Assist with development strategy and preparation for team/project meetings
• Assist with the development and/or review of regulatory documents to ensure that all submissions are of high quality:
  • coordinate, and organize regulatory information, data, documents, and other information in support of regulatory filings or procedures 
  • interface with functional areas (Development, Operations, QA, QC, Engineering) to obtain information identified by the Regulatory Affairs Lead as required for regulatory submissions
  • Assists Regulatory Affair’s Leads with preparing, coordinating, assembly and lifecycle management of regulatory dossiers for investigational product applications, annual reports, and information amendments.
  • Assists Regulatory Affair’s Leads with preparing, coordinating, assembly and lifecycle management of regulatory dossiers for Regulatory Authority peri-approval procedures, Marketing Authorization, or Clearance procedures 
  • Assists Regulatory Affair’s Leads with preparing, coordinating, assembly of Agency Information Requests/Query responses  •
• Compile information and maintain regulatory documentation databases and information management systems in compliance with regulatory requirements
  • Management of Regulatory Authority Communication Logs, Compliance activity logs, Product Portfolio and Asset Information, 
  • Scans, files, and archives documents
  • Ensure all regulatory documentation is compliant with Standard Operating Procedures (SOP’s) for format, content, and storage.
• Provide administrative support for the activities conducted by the Regulatory Affairs Department including:
  • Preparing, coordinating, and organizing data and other information in support of regulatory business reporting and information management
  • summarizing correspondence and/or providing meeting minutes or dashboard updates to/for related activities
  • scheduling meetings, expense tracking and submission as well as travel planning, purchase order and vendor creation. 
• Provide summaries of complex communication and follow-up to ensure proper and timely action is taken in the Regulatory Affairs Centralized Services function including activities related to but not exclusive of:
• Supports supervisor’s role 

Location

13631 Progress Blvd., Alachua, FL 32615

OR

111 West Oak Ave., Tampa, FL  33602

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Benefits/Compensation