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Regulatory Affairs Associate at Globus Medical Inc - ApplyBlast

Regulatory Affairs Associate

Globus Medical Inc

1 month ago

Audubon, Pennsylvania, United States

Onsite

Full Time

Junior

0 applicants

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About this role

The Regulatory Affairs Associate assists in drafting, submitting, and gaining clearance for FDA submissions, including 510(k), IDE, and PMA packages for class II and III medical devices. This role requires working knowledge of relevant regulations and guidance documents to support product development and management. The position involves building effective working relationships with internal teams while ensuring compliance with FDA 21 CFR regulations.

Responsibilities

Draft and submit 510(k) and IDE/PMA applications to the FDA
Review clinical study data and document change orders for regulatory compliance
Maintain approved PMAs and coordinate preparation of PMA supplements and annual reports

Skills

Qualifications

Bachelor's degree in health or science-related fieldEngineering degree

About Globus Medical Inc

globusmedical.com

Headquarters

Valley Forge, Pennsylvania, United States

Company Size

1001-5000 employees

Founded

2003

View Profile

Globus Medical develops, manufactures, and distributes musculoskeletal device solutions, including implants and enabling technologies for spine, orthopedic trauma, and joint reconstruction procedures. The company offers a comprehensive portfolio of products such as robotic navigation systems, interbody spacers, fixation systems, regenerative biologics, and surgical power tools. Globus Medical serves surgeons, patients, and healthcare professionals with the goal of improving patient care and outcomes.