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Regulatory Associate at Globus Medical Inc - ApplyBlast

Regulatory Associate

Globus Medical Inc

4 months ago

Remote

Full Time

Junior

0 applicants

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About this role

Regulatory Affairs Associate at Globus Medical assists in drafting, submitting, and gaining clearance for 510(k) and IDE/PMA submissions to the FDA for medical devices.

Responsibilities

Partnering with Product Development and management to prepare and review 510(k) submissions
Preparing final 510(k) submissions and obtaining required management approvals
Submitting 510(k) documents and responding to the FDA in a timely manner
Assisting in the completion of IDE submissions for IDE clinical trials
Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections

Skills

Qualifications

Bachelor’s degree in health or science-related field, or equivalent; Engineering degree is a plusKnowledge of US Code of Federal Regulations Title 21Minimum of 0-2 years’ experience in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plusExcellent communication and listening skillsProficient with Microsoft Office, including Word, Excel, PowerPoint and Teams

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.