Regulatory Affairs Specialist I - Medical Devices (510(k), CE)

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 strategies and submissions for medical devices in the US and international markets. The role emphasizes collaboration with project teams, reviewers, and internal stakeholders to ensure compliant product life cycle handling.

Minimum requirements include a BS in a scientific field with 1+ year in regulatory or quality roles; RAC is desirable and knowledge of US/EU regulations is preferred.

Qualifications

• BS in a scientific field with 1+ years in medical device registration, compliance or quality systems.
• Regulatory Affairs Certification (RAC) desired.
• Knowledge of U.S. and European medical device regulations preferred.
• Ability to handle regulatory documentation with confidentiality and accuracy.

Responsibilities

• Provide regulatory support through the product life cycle on project teams.
• Prepare and audit 510(k)s, IDEs, PMA 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 knowledge

FDA submissions

Documentation

Communication

Project management

Education

BS in a scientific field

RAC desired

Job description

BD is seeking a Regulatory Affairs Specialist I to support regulatory strategies and submissions for medical devices in the US and international markets. The role emphasizes collaboration with project teams, reviewers, and internal stakeholders to ensure compliant product life cycle handling.

Minimum requirements include a BS in a scientific field with 1+ year in regulatory or quality roles; RAC is desirable and knowledge of US/EU regulations is preferred.