International Regulatory Specialist

International Regulatory Specialist

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.

Position Summary:

The International Regulatory Specialist will be responsible for drafting, submitting, and gaining approval of product registrations and other submissions to international regulatory agencies.

Essential Functions:

• 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; and
• Ensure conformance to International Organization for Standardization (ISO), Conformit Europenne (CE), Food & Drug Administration (FDA) and other international/local regulations.
• Up to 10% domestic and international travel required to visit hospitals, medical buildings, customer sites, etc.

Qualifications:

• 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; and
• Experience preparing key regulatory deliverables, including Letters to File (LTF), Regulatory Release Memos, and Regulatory Analyses for FDA 510(k)-cleared products.

Our Values :

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

• Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused : We listen to our customers' needs and respond with a sense of urgency.
• Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity :

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.

Other Duties :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.