Regulatory Affairs Specialist I, Medical Devices

BD; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

BD is seeking a Regulatory Affairs Specialist I to support regulatory submissions and lifecycle activities for Urology and Critical Care products. You will coordinate US and international submissions, interact with FDA reviewers, and contribute to labeling, compliance, and CE marking efforts.

Ideal candidates hold a BS in a scientific field with 1+ year regulatory experience, strong writing skills, and the ability to manage multiple projects with diligence and accuracy.

Qualifications

• BS in a scientific field; 1+ year in regulatory/quality
• RAC preferred
• Knowledge of US/EU medical device regs preferred
• Confidentiality in regulatory docs
• Excellent written and verbal communication skills

Responsibilities

• Provide regulatory support through product life cycle on project teams
• Prepare and audit 510(k)s, IDEs, PMA and international submissions
• 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 affairs

510(k) submissions

FDA communications

Technical writing

GMP/ISO knowledge

Education

Bachelor's degree in a scientific field

Tools

Regulatory submissions tools

Quality management systems

Job description

BD is seeking a Regulatory Affairs Specialist I to support regulatory submissions and lifecycle activities for Urology and Critical Care products. You will coordinate US and international submissions, interact with FDA reviewers, and contribute to labeling, compliance, and CE marking efforts.

Ideal candidates hold a BS in a scientific field with 1+ year regulatory experience, strong writing skills, and the ability to manage multiple projects with diligence and accuracy.