Sr Regulatory Affairs Specialist

Globus Medical Job Posting

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

Coordinates and prepares document packages, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications.

Essential Functions

• Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations
• Collaborates with various departments to review the required plans, procedures and regulatory decisions for existing products
• Reviews regulatory requirements from other departments for product designs or changes to existing designs
• Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
• Supports product import by providing applicable regulatory documentation and certificates
• Performs other duties as assigned Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

Physical Demands

The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.

Our Values

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

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.