Regulatory Affairs Specialist II - 4 On-Site, Friday Remote

BD; Covington (GA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

BD is seeking a Regulatory Affairs Specialist II in Covington, GA. This role supports domestic and international regulatory submissions and product lifecycle responsibilities, with a 4-day on-site and one remote day per week setup.

Excellent writing and communication skills are essential to drive timely approvals and maintain compliance. The position requires a BS in a scientific field with 3–5 years in medical device registrations; RAC is preferred.

Qualifications

• BS in a scientific field with 3–5 years in medical device product registration.
• Experience preparing and auditing 510(k)s, IDEs, PMA and international submissions.
• Knowledge of U.S. and European medical device regulations.
• Excellent written and verbal communication; ability to work independently.

Responsibilities

• Provide regulatory support through product lifecycle on project teams.
• Prepare and audit 510(k)s, IDEs, PMA and international submissions.
• Collaborate with FDA and international reviewers; respond to questions.
• Review and approve labeling and marketing claims for regulatory compliance.
• Support CE marking activities; maintain technical files and clinical evaluations.
• Provide training or direction to other regulatory team members.

Skills

Regulatory strategy

510(k) submissions

Technical writing

Leadership & mentoring

US/EU regulatory knowledge

Communication skills

Education

BS in a scientific field

RAC desirable

Job description

BD is seeking a Regulatory Affairs Specialist II in Covington, GA. This role supports domestic and international regulatory submissions and product lifecycle responsibilities, with a 4-day on-site and one remote day per week setup.

Excellent writing and communication skills are essential to drive timely approvals and maintain compliance. The position requires a BS in a scientific field with 3–5 years in medical device registrations; RAC is preferred.