Regulatory Affairs Specialist II — Medical Devices

Regulatory Jobs; Covington (GA); Hybrid; USD 85,000 - 110,000; Full time

Job summary

BD, a leading global medical technology company, is hiring a Regulatory Affairs Specialist II for on-site work in Covington, GA with weekly remote Fridays. You will implement regulatory strategies and support domestic and international submissions across product lifecycles.

Responsibilities include preparing 510(k)s, IDEs, PMAs, and CE marking documents, collaborating with FDA and international regulators, ensuring compliant labeling, and mentoring junior staff.

Qualifications

• BS in a scientific field with 3-5 years in medical device product registration.
• 2+ years regulatory support through product life cycle on project teams.
• Experience preparing and auditing 510(k)s, IDEs, PMA and/or international submissions.
• Experience reviewing and approving product labeling and marketing claims for regulatory compliance.
• Supporting CE marking activities, including preparation and maintenance of product technical files and clinical evaluations.
• Previous experience training or direction to other regulatory team members.
• RAC desired

Responsibilities

• Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
• Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
• Provide technical collaborate with FDA and international reviewers and respond to questions
• Provide timely review and approval of product labeling and marketing claims for regulatory compliance
• Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations

Skills

Regulatory knowledge (U.S. & EU)

Communication skills

Self-motivation

Project prioritization

Technical writing

Leadership

Confidentiality

Education

BS in a scientific field

Regulatory Affairs Certification (RAC) desired

Job description

BD, a leading global medical technology company, is hiring a Regulatory Affairs Specialist II for on-site work in Covington, GA with weekly remote Fridays. You will implement regulatory strategies and support domestic and international submissions across product lifecycles.

Responsibilities include preparing 510(k)s, IDEs, PMAs, and CE marking documents, collaborating with FDA and international regulators, ensuring compliant labeling, and mentoring junior staff.