International Regulatory Specialist

Globus Medical • Audubon, PA

29d • Onsite

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. The International Regulatory Specialist will be responsible for drafting, submitting, and gaining approval of product registrations and other submissions to international regulatory agencies.

Requirements

• Requires a Bachelor’s degree or foreign equivalent in engineering or a relevant scientific field (Biology, Chemistry, Physics, Pharmacy, etc.) or related field
• 5 years of experience in a related occupation
• Experience ensuring compliance with U.S. FDA and international regulatory requirements
• Experience providing expert regulatory guidance to development project teams, contributing to the formulation of comprehensive regulatory strategies for innovative medical devices and new product introductions
• Experience evaluating proposed product and process changes to determine their impact on regulatory status across U.S. and global markets
• Experience researching and analyzing regulatory requirements
• Experience offering regulatory feedback for various transfer and remediation projects
• Experience coordinating and contributing to the preparation and submission of Technical Documentation for EU MDR submissions, including significant change notifications
• Experience performing detailed regulatory gap assessments to identify compliance deficiencies and recommending corrective actions in line with current industry and regulatory standards
• Experience preparing key regulatory deliverables, including Letters to File (LTF), Regulatory Release Memos, and Regulatory Analyses for FDA 510(k)-cleared products

Responsibilities

• Work in conjunction with other departments to develop submissions
• Partner with Product Development, Quality Assurance, and management to prepare and review international regulatory submissions including CE technical files and design dossiers, and other international filings, to obtain marketing clearance
• Obtain timely marketing clearance for all products in parallel with US submissions
• Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as they pertain to international regulations
• Coordinate, review and submit product labeling for marketing outside the U.S.
• Review design changes and technical files for updates to documentation
• Prepare and file certificates to foreign governments with FDA
• Develop relevant regulatory SOPs as necessary
• Ensure conformance to International Organization for Standardization (ISO), Conformité Européenne (CE), Food & Drug Administration (FDA) and other international/local regulations

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level