APAC Regulatory Affairs Expert — Medical Devices

Arthrex; Naples (FL); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Annual Bonus

Paid Time Off

Onsite Medical Clinics

Onsite Lunch

Tuition Reimbursement Program

Job summary

Arthrex, Inc. in Naples, FL is seeking an International Regulatory Affairs Specialist - APAC to support global registrations for leading medical devices. The role requires a Bachelor’s degree and 2+ years of RA experience for Specialist II, or 5+ years for Senior.

You will collaborate across Engineering, R&D, Manufacturing, and QA to prepare regulatory submissions and maintain approvals. Join a team focused on helping surgeons treat their patients better, with opportunities for international

Qualifications

• Bachelor's degree required.
• RA Specialist II - 2+ years relevant RA experience supporting medical device registrations/licenses/submissions and quality audit requests.
• RA Specialist Senior - 5+ years relevant RA experience supporting registrations/licenses/submissions and quality audit requests.

Responsibilities

• Research and respond to inquiries to facilitate new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests, and international marketing bids.
• Coordinate with Engineering, R&D, Manufacturing, Quality Assurance, and other departments to collect technical information for regulatory documents.
• Provide technical review of data or reports for regulatory agencies to ensure accuracy and compliance.
• Manage and process Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.
• Develop and conduct employee training for International Regulatory Affairs.

Skills

Regulatory affairs

Medical devices

Technical writing

Cross-functional collaboration

Education

Bachelor's degree

Tools

SAP

Excel

Word

PowerPoint

Adobe Acrobat

Job description

Arthrex, Inc. in Naples, FL is seeking an International Regulatory Affairs Specialist - APAC to support global registrations for leading medical devices. The role requires a Bachelor’s degree and 2+ years of RA experience for Specialist II, or 5+ years for Senior.

You will collaborate across Engineering, R&D, Manufacturing, and QA to prepare regulatory submissions and maintain approvals. Join a team focused on helping surgeons treat their patients better, with opportunities for international