Summary

The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring 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 internal teams while following FDA 21 CFR regulations.

Job description

Position Summary

The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring 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 internal teams while following FDA 21 CFR regulations.

Essential Functions

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
Working with personnel in various functional areas to obtain timely submissions to FDA
Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes
Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
Assisting in Regulatory Pathway Form determinations under departmental guidelines
Administrative tasks, such as filing, scanning, organizing file, as needed. Reviewing and filing Note-to-File documentation for minor changes to 510(k) cleared products or systems
Understanding the company’s products, surgical techniques and the use of implant and instrument systems

Requirements

Bachelor’s degree in health or science-related field, or equivalent; Engineering degree is a plus
Knowledge of US Code of Federal Regulations Title 21
Minimum of 0-2 years’ experience in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus
Excellent communication and listening skills
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
Strong time management skills, with the ability to work on multiple projects simultaneously
Able to work independently as well as within a team

Company overview

Globus Medical, Inc. is a leading publicly traded orthopedic medical device company headquartered in Audubon, Pennsylvania, founded in 2003. The company specializes in the design, development, and commercialization of innovative musculoskeletal solutions that enable surgeons to promote healing in patients with musculoskeletal disorders. Globus Medical has established itself as the fastest growing company in the history of orthopedics through its single-minded focus on advancing surgical technologies. The company's comprehensive product portfolio includes spinal implants, trauma solutions, artificial joints, and the revolutionary ExcelsiusGPS surgical robotic system for spine surgery. Their robotic navigation technology provides sub-millimeter accuracy for transpedicular drilling and screw placement procedures. Globus Medical also offers advanced surgical planning software and registry solutions like SpineTRACK and OrthoTRACK for comprehensive treatment outcomes data collection. The company's mission is to utilize superior engineering and technology to achieve pain-free, active lives for all patients, driving significant technological advancements across a complete suite of orthopedic products.