Regulatory Affairs Associate — Medical Devices

Globus-Medical; Lower Providence Township (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

Globus Medical seeks a Regulatory Affairs Associate to draft, submit, and secure FDA clearances for 510(k), IDE, and PMA projects. You will work with Product Development and cross-functional teams to prepare comprehensive regulatory submissions and ensure compliance with 21 CFR regulations.

Knowledge of device regulations and strong collaboration are essential. Ideal candidates have a health/science background, 0–2 years in medical devices, and proficiency with MS Office to manage documentation,

Qualifications

• Bachelor’s degree in health or science-related field or equivalent.
• Knowledge of US Code of Federal Regulations Title 21.
• 0–2 years’ experience in medical device industry; regulatory affairs experience is a plus.
• Excellent communication and listening skills.
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Teams).

Responsibilities

• Prepare and review 510(k) submissions.
• Prepare final 510(k) submissions and obtain required approvals.
• Submit 510(k) documents and respond to FDA promptly.
• Assist IDE submissions for IDE clinical trials.
• Help prepare PMA packages (non-clinical, manufacturing, clinical sections).
• Coordinate with cross-functional teams to ensure timely FDA submissions.
• Review and file regulatory documentation and change orders.
• Maintain PMAs and prepare supplements and annual reports.

Skills

Regulatory affairs knowledge

Communication skills

Time management

Independent work

Education

Bachelor’s degree in health or science-related field

Engineering degree is a plus

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Teams

Job description

Globus Medical seeks a Regulatory Affairs Associate to draft, submit, and secure FDA clearances for 510(k), IDE, and PMA projects. You will work with Product Development and cross-functional teams to prepare comprehensive regulatory submissions and ensure compliance with 21 CFR regulations.

Knowledge of device regulations and strong collaboration are essential. Ideal candidates have a health/science background, 0–2 years in medical devices, and proficiency with MS Office to manage documentation,