International Regulatory Affairs Specialist - APAC

Title: International Regulatory Affairs Specialist - APAC

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Regulatory Affairs Specialist II, and RA Specialist Senior for our global headquarters in Naples, Fl. The ideal candidate for Specialist II will have a Bachelor's degree and 2+ years relevant RA experience, preferrably in the medical device industry.

The Senior Specialist will have a Bachelor's degree and 5 years relevant experience. The International Regulatory Affairs Specialists advance Arthrex’s global market access by providing technical support to Arthrex subsidiaries and distributors to achieve and/or maintain regulatory and quality approval/clearance/registration/licensure/certifications for Arthrex’s medical devices in the most efficient and least burdensome approach to meet business needs while maintaining compliance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• Research and respond to inquiries from Arthrex subsidiaries and distributors to facilitate new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests, international marketing bid/tenders and to support quality tasks related to foreign manufacturer registrations.
• Coordinate with Engineering, R&D, Manufacturing, Quality Assurance, and other applicable departments to collect technical information and data associated with the preparation of international regulatory documents to support Arthrex subsidiaries and distributors new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests and international marketing bid/tenders.
• Provide technical review of data or reports to be provided to regulatory agencies to ensure scientific rigor, accuracy, clarity of presentation, completeness, consistency, and conformance to regulations and guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability.
• Manage and process requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.
• Provide feedback and on-going support to Arthrex subsidiaries and distributors to resolve (potential) regulatory issues and inquiries from regulatory agencies - offering solutions, as applicable.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Partner with in-country Regulatory and Quality staff to identify international regulations, guidances, policies, and/or procedures for changes and ensure change notification to Regulatory leadership and appropriate stakeholders.
• Recommend changes to company procedures in response to changes in regulations, guidances and/or standards.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits.
• Develop and/or conduct employee training for International Regulatory Affairs.

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