MedTech Regulatory Affairs Coordinator II – Impact & Compliance

BD; Covington (GA); On-site; USD 60,000 - 85,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health through innovative solutions. The Regulatory Affairs team drives change management, documentation, and compliance across all product lines.

In this role, you will coordinate regulatory change processes, prepare registrations and STEDs, and support SOP and policy updates. On-site collaboration is expected to maintain BD's culture of excellence in a fast-paced healthcare environment.

Qualifications

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

Responsibilities

• Coordinates Regulatory Change Management: evaluate requests, compile info, summarize responses and maintain EDMS.
• Prepare regulatory documentation including registrations, STEDs, dossiers; manage word processing for FDA docs and reports.
• Coordinate external requests for product data; liaise with clients on regulatory matters.
• Update SOPs, Work Instructions, and policies to ensure compliance with current standards.
• Handle departmental admin: ordering supplies, purchase requisitions, correspondence for regulatory team needs.

Skills

Regulatory knowledge

Attention to detail

Project management

Communication skills

Notary Public

Education

High School diploma or equivalent

Bachelor Degree, BS

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Microsoft Outlook

Job description

BD is a leading global medical technology company focused on advancing health through innovative solutions. The Regulatory Affairs team drives change management, documentation, and compliance across all product lines.

In this role, you will coordinate regulatory change processes, prepare registrations and STEDs, and support SOP and policy updates. On-site collaboration is expected to maintain BD's culture of excellence in a fast-paced healthcare environment.