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axogen · 1 day ago

Regulatory Affairs Specialist

Tampa, FL

Full-time

Onsite

Entry Level

$63K/yr - $79K/yr

1+ years exp

Axogen is dedicated to restoring health and improving quality of life through innovative solutions in peripheral nerve function. The Regulatory Affairs Specialist will assist in navigating regulatory approval procedures and managing regulated information, serving as a crucial link between various teams within the organization.

BiotechnologyMedicalMedical Device

Culture & Values

Responsibilities

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

Assist Regulatory Affairs Leads with preparing, coordinating, assembling, and lifecycle management of regulatory dossiers for investigational product applications, annual reports, and information amendments

Assists Regulatory Affairs Leads with preparing, coordinating, assembling, and lifecycle management of regulatory dossiers for Regulatory Authority peri-approval procedures, Marketing Authorization, or Clearance procedures

Assists Regulatory Affairs Leads with preparing, coordinating, and assembling Agency Information Requests/Query responses

Compiles information and maintains 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

Ensures all regulatory documentation is compliant with Standard Operating Procedures (SOP’s) for format, content, and storage

Provides 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

Supports the supervisor’s role

Qualification

Regulatory Affairs experienceLife sciences degreeProject managementCommunication skillsProblem-solving abilitiesTechnological aptitudeMedical terminology knowledgeAttention to detailTeam collaboration

Required

A degree or certification-level qualification in a relevant life sciences discipline (i.e. an Associate Degree or 1-3 years' work experience) 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