Regulatory Affairs Coordinator II — Compliance & Documentation

Regulatory Jobs; Covington (GA); On-site; USD 45,000 - 65,000; Full time

Job summary

BD is a leading global medical technology company committed to advancing health. This role supports Regulatory Change Management, prepares essential registrations and dossiers, and maintains documentation in EDMS. You will liaise with Regulatory Affairs specialists and update SOPs to ensure compliance with current requirements.

On-site presence is required to foster collaboration and efficient operations. The position emphasizes precise document control, timely responses to customer data

Qualifications

• High School diploma or equivalent in a regulated environment
• 1-3 years Regulatory Affairs or Quality Assurance experience with medical technology companies
• Proficient in using Microsoft Word, Access, Excel and Outlook

Responsibilities

• Coordinates the Regulatory Change Management process by evaluating requests, compiling information, and summarizing responses. Administers regulatory team systems and uploads documentation to EDMS.
• Works with Regulatory Affairs Specialists to prepare registrations, STEDs, and dossiers; handles word processing for FDA documents, status reports, and presentations.
• Coordinates and responds to external requests for product data, surveys, and questionnaires from customers as a liaison on regulatory matters.
• Updates SOPs, Work Instructions, and policies to maintain compliance with regulatory requirements and internal standards.
• Handles departmental administrative functions including ordering supplies, creating purchase requisitions, and managing correspondence.

Skills

Regulatory knowledge

Documentation management

Communication

Education

Bachelor Degree in related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Microsoft Outlook

Job description

BD is a leading global medical technology company committed to advancing health. This role supports Regulatory Change Management, prepares essential registrations and dossiers, and maintains documentation in EDMS. You will liaise with Regulatory Affairs specialists and update SOPs to ensure compliance with current requirements.

On-site presence is required to foster collaboration and efficient operations. The position emphasizes precise document control, timely responses to customer data