Regulatory Affairs Specialist I — MedTech Submissions

Becton Dickinson; Covington (GA); On-site; USD 70,000 - 100,000; Full time

Job summary

Becton Dickinson in Covington, GA is seeking a Regulatory Affairs Specialist I to support regulatory strategies and submissions for medical devices across the product lifecycle, collaborating on domestic and international registrations.

The role emphasizes preparing 510(k)s, IDEs, and PMAs, maintaining regulatory documentation, and ensuring labeling compliance while communicating with FDA and regulators worldwide to keep products on schedule.

Qualifications

• BS in a scientific field with 1+ years in medical device regulatory areas or equivalent
• Regulatory Affairs Certification (RAC) desired
• Knowledge of U.S. and European medical device regulations preferred
• Confidential handling of regulatory and clinical documentation
• Excellent written and verbal communication skills

Responsibilities

• Provide regulatory support through the product lifecycle on project teams
• Prepare and audit 510(k)s, IDEs, PMAs and international submissions as required
• Collaborate with FDA and international reviewers and respond to questions
• Review and approve product labeling and marketing claims for regulatory compliance
• Support CE marking activities including technical files and clinical evaluations

Skills

Regulatory communication

Time management

Technical writing

Independent work

Education

Bachelor's degree in science

Job description

Becton Dickinson in Covington, GA is seeking a Regulatory Affairs Specialist I to support regulatory strategies and submissions for medical devices across the product lifecycle, collaborating on domestic and international registrations.

The role emphasizes preparing 510(k)s, IDEs, and PMAs, maintaining regulatory documentation, and ensuring labeling compliance while communicating with FDA and regulators worldwide to keep products on schedule.