Regulatory Affairs Coordinator II Driving Compliance & Impact

Becton Dickinson; Covington (GA); On-site; USD 52,000 - 75,000; Full time

Job summary

Becton, Dickinson and Company is seeking a Regulatory Affairs Support professional to coordinate the Regulatory Change Management process and maintain regulatory documentation in our EDMS in Covington, GA. You will prepare registrations, STEDs, and dossiers, manage word processing for FDA documents, and act as a liaison with customers on regulatory matters.

Strong organizational skills and detail orientation are essential.

Qualifications

• High School diploma or equivalent experience 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

• Coordinate the Regulatory Change Management process by evaluating requests, compiling information, and summarizing responses
• Administer regulatory team systems and upload documentation to EDMS, ensuring materials are properly maintained and accessible
• Prepare registrations, STEDs, and dossiers for regulatory submissions
• Manage word processing needs including FDA documents, certificates, status reports, and presentations
• Coordinate and respond to external requests for product data, surveys, and questionnaires from customers
• Update Standard Operating Procedures (SOPs), Work Instructions (WIs), and policies to maintain regulatory compliance
• Handle departmental administrative functions including ordering supplies, creating purchase requisitions, and managing correspondence

Skills

Regulatory affairs

Quality assurance

Strong communication

Project management

Multitasking

Attention to detail

Notary Public

Education

High School diploma or equivalent

Bachelor Degree, BS

Tools

Microsoft Word

Microsoft Access

Microsoft Excel

Microsoft Outlook

Job description

Becton, Dickinson and Company is seeking a Regulatory Affairs Support professional to coordinate the Regulatory Change Management process and maintain regulatory documentation in our EDMS in Covington, GA. You will prepare registrations, STEDs, and dossiers, manage word processing for FDA documents, and act as a liaison with customers on regulatory matters.

Strong organizational skills and detail orientation are essential.