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 youll love working atAxogen :

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto 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

Responsibilities of the Regulatory Affairs Specialist

T he R egulatory A ffairs S pecialist 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 :

Coordinate and organize regulatory information data documents and other information in support of regulatory filings or procedures

Management of Regulatory Authority Communication Logs Compliance activity logs Product Portfolio and Asset Information

Preparing coordinating and organizing data and other information in support of regulatory business reporting and information management

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

$61194 $76491 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.

Required Experience :

IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full Time

Experience : years

Vacancy : 1