Regulatory Affairs Coordinator II

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

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description Responsibilities

Coordinates the Regulatory Change Management process by evaluating requests, compiling information, and summarizing responses. Administers regulatory team systems and uploads documentation to Electronic Document Management System (EDMS), ensuring all regulatory materials are properly maintained and accessible. Works closely with Regulatory Affairs Specialists to prepare critical regulatory documentation including registrations, Summary Technical Electronic Documentation (STEDs), and dossiers. Manages extensive word processing needs including FDA documents, certificates, status reports, and presentations. Coordinates and responds to external requests for product data, information, surveys, and questionnaires from customers, serving as a key liaison between the organization and its clients for regulatory matters. Takes responsibility for updating Standard Operating Procedures (SOPs), Work Instructions (WIs), and policies as needed, ensuring the department maintains compliance with current regulatory requirements and internal standards. Handles departmental administrative functions including ordering supplies, creating purchase requisitions using applicable systems, and managing correspondence to support the regulatory affairs team's operational needs.

Minimum Requirements

• 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

Preferred Requirements

• Bachelor Degree, BS
• Strong communication and project management skills
• Must be able to balance multiple tasks
• Attention to details
• Knowledge of Medical Device Quality Systems and Good Documentation Practices
• Able to be Notary Public

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills Optional Skills .

Primary Work Location USA GA - Covington BMD Additional Locations Work Shift US BD 1st Shift 8am-430pm (United States of America)

We are the MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.