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About Us:
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 Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating products in alignment with company policies as well as audits and inspections (internal and external), and oversight of global submission requirements, license renewal and annual registration maintenance. The Lead Specialist will be expected to contribute to the registration and maintenance of medical devices of all classifications; able to advise on changes impacting product performance (such as labeling, manufacturing, marketing and clinical development) for regulatory compliance, keeping abreast of regulatory procedures and changes and leading implementation. This role will be instrumental in facilitating strategic interaction with regulatory agencies on defined matters. The Lead Specialist will input to registration strategies for earliest possible approvals of clinical trials applications, as well as market introduction.
Essential Functions:
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
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.
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
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.
Full Time
Medical Technology
$115k-148k (estimate)
03/22/2024
07/13/2024
globusmedical.com
AUDUBON, PA
1,000 - 3,000
2003
Public
DAVID M DEMSKI
$500M - $1B
Medical Technology
Globus Medical manufactures and commercializes musculoskeletal implants for the treatment of spinal disorders.