Associate 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 Associate maintains CE Technical Files and registrations for international Regulatory agencies. This position entails working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with development teams while following ISO, CE, FDA and international/local regulations. Experience should demonstrate dependability, flexibility and attention to detail.  

Essential Functions:

• Under supervision of Group Manager, obtain the necessary documentation from Product Development, Quality Assurance, and management needed to maintain existing CE Technical Files.

• Assist in the maintenance of regulatory approval and tracking documents.

• Assemble documentation in support of regulatory submissions. 

• Provide regulatory support as needed within Regulatory Affairs.

• Review technical documents intended for submissions.

• Maintain regulatory files.

• Perform literature searches and extract information to support regulatory submissions.

• Assist with review of labeling and clinical reports for regulatory compliance. Assist in the coordination of product labeling revisions for marketing outside the United States.

• File Certificates to Foreign Governments with FDA.

• Monitor FDA and other agency laws and regulations, to ensure company compliance Ensure conformance to ISO, CE, FDA and other international/local regulations.

• Understand spinal and orthopedic surgical techniques and the use of spinal and orthopedic devices and instrument systems.

• 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:

• Four-year college degree or equivalent.   

• Experience in a regulated industry such as medical devices is a plus. 

• Excellent verbal, written and organizational skills. Good computer skills.

• Must be detail-oriented and able to multi-task.

Physical Demands:

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

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl

• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

• Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception

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.