Intern, Regulatory Affairs International Labeling Support

Alachua, FL - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Summary of the Regulatory Affairs (International Labeling Support) Internship

We are seeking an enthusiastic and detail-oriented intern to assist with an International Labeling project. This position will support the Regulatory Affairs team in preparing and reviewing international labeling documentation for a processed tissue allograft product. The intern will gain hands-on experience in regulatory affairs particularly in international labeling compliance regulatory document preparation and cross-functional communication. The primary focus will be on labeling requirements in international markets including Israel Chile Austria Singapore Denmark the UK Spain Switzerland New Zealand Taiwan Canada and Germany.

Requirements of the Regulatory Affairs (International Labeling Support) Internship

Currently enrolled in an undergraduate or graduate program preferably in Regulatory Affairs Life Sciences Biology Healthcare Compliance or a related field. (Up to one year post-graduation is also eligible).
Ability to work a minimum of 20 hours per week during normal business hours (8-5pm); specific days/hours will be based on the students class load
No prior regulatory experience is required but previous internships or coursework related to regulatory affairs labeling or healthcare compliance is a plus
Ability to pass a drug screening
Able to work out of the Alachua office
Strong attention to detail and ability to manage multiple tasks.
Excellent written and verbal communication skills.
Proficiency in Microsoft Office (Word Excel PowerPoint).
Strong organizational and time management skills.

Project Details

Labeling Support: Assist in the preparation and revision of international labeling documents ensuring compliance with regulatory requirements in multiple global markets (e.g. EU Canada Israel Chile and others).
Document Review: Help review and ensure the accuracy and compliance of labeling content with the regulations and standards of the target markets.
Regulatory Research: Conduct research on regulatory requirements for labeling in target markets including specific documentation and language requirements for tissue-based products and summarize findings.
Project Coordination: Collaborate with the Regulatory Affairs team project managers and other stakeholders to ensure timely completion of project milestones.
Data Management: Organize and maintain regulatory files ensuring that all documents are properly tracked and stored in accordance with company standards.
Cross-Functional Collaboration: Work closely with cross-functional teams to align on labeling content and ensure consistency across regions.

Location

13631 Progress Blvd. Alachua FL 32615

Compensation

The anticipated base wage for this position is $18/hr for an undergrad student and $20/hr for a grad addition to the base hourly rate there may be a housing stipend available based on location. Interns who are 21 years of age or older are eligible for 401K.

#LI-AC1

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:

Intern