ApplyBlast uses AI to match you with the right jobs, tailor your resume and cover letter, and apply automatically so you can land your dream job faster.

Features

Auto Apply Resume Optimizer Cover Letter Optimizer Interview Prep

Company

Social Media

Need Help?

team@applyblast.com

Regulatory Associate at Globus Medical Inc - ApplyBlast

Regulatory Associate

Globus Medical Inc

3 months ago

Audubon, PA

Onsite

Full Time

Junior

1 applicant

View Job Listing

Apply to 100+ jobs

About this role

The Regulatory Affairs Associate supports the preparation, submission, and clearance of FDA documents for medical devices, including 510(k), IDE, and PMA submissions. This role involves collaborating with product development and clinical teams to ensure compliance with FDA regulations while managing document change orders and maintaining approved product files.

Responsibilities

Draft and submit 510(k) and IDE/PMA documents to the FDA
Review document change orders for regulatory compliance
Coordinate with clinical teams for study data reporting
Maintain approved PMAs and prepare annual reports
Ensure adherence to FDA 21 CFR regulations

Skills

Qualifications

Bachelor's degree in health or science-related fieldKnowledge of US Code of Federal Regulations Title 21

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.