Global Regulatory Affairs Lead, International (EMEA)

Oncology Voice Network LLC; Naples (FL); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical Dental and Vision Insurance

Company-Provided Life Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Tuition Reimbursement Program

Paid Time Off

Paid Parental Leave

Free Onsite Medical Clinics

Free Onsite Lunch

Wellness Incentive Program

Employee Assistance Program (EAP)

Job summary

Arthrex, a global medical device company, seeks a Senior Specialist, International Regulatory Affairs for its Naples, FL headquarters. You will advance global market access by supporting registrations, renewals and certifications for devices in the EMEA region, coordinating with subsidiaries and distributors.

The role requires a Bachelor’s degree and 5+ years of regulatory affairs experience, with proficiency in SAP and Microsoft Office.

Qualifications

• Bachelor's degree required in a relevant field.
• 5+ years of regulatory affairs experience for medical devices.
• Experience supporting registrations, licenses, and certifications internationally.

Responsibilities

• Research and respond to inquiries to facilitate registrations, renewals, and changes.
• Coordinate with Engineering, R&D, Manufacturing, QA and other departments to collect regulatory data.
• Provide technical review of documents for regulatory submission and ensure compliance.
• Manage Certificates to Foreign Government, Certificates of Manufacture and Free Sale.
• Support internal/outside audits and participate in training for International Regulatory Affairs.

Skills

Regulatory affairs

SAP

Microsoft Office

Education

Bachelor's degree

Tools

Adobe Acrobat

Excel

Word

PowerPoint

Job description

Arthrex, a global medical device company, seeks a Senior Specialist, International Regulatory Affairs for its Naples, FL headquarters. You will advance global market access by supporting registrations, renewals and certifications for devices in the EMEA region, coordinating with subsidiaries and distributors.

The role requires a Bachelor’s degree and 5+ years of regulatory affairs experience, with proficiency in SAP and Microsoft Office.