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Globus Medical
Audubon, PA; Pennsylvania - Audubon - Headquarters
Source: Globus Medical careers · View original posting
From Globus Medical's posting. “We” and “our” refer to the employer.
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 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.
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.
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.
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