Regulatory Affairs Specialist

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you’ll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives

• Company-wide dedication to profoundly impacting patients’ lives

• Comprehensive, high-quality benefits package effective on date of hire

• Educational assistance available for all employees

• Matching 401(k) retirement plan

• Paid holidays, including floating holidays, to be used at your discretion

• Employee Stock Purchase Plan

• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

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 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

• 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

Location

13631 Progress Blvd., Alachua, FL 32615

OR

111 West Oak Ave., Tampa, FL 33602

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range
$63,030—$78,786 USD

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.