JOB DESCRIPTION SUMMARY

BD is seeking a Regulatory Affairs Specialist II to join our team in Covington, GA. This is a hybrid role with 4 days working at our office. The Regulatory Affairs Specialist II is responsible for implementing strategies, including domestic and international submissions, and providing support to product project teams throughout the product life cycle.

SUMMARY

The Regulatory Affairs Specialist II is responsible for implementation of strategies including domestic and international submissions and other support of product project team.

REQUIREMENTS

• 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, PMAs, and/or international submissions as required
• Provide technical collaboration with FDA and international reviewers and respond to questions
• Provide timely review and approval of product labeling and marketing claims for regulatory compliance
• Update STED technical files for CE marking activities and notified body interaction to accomplish EU/MDR product
• May direct Project Team personnel; may provide direction to assistant personnel

EDUCATION

Bachelor’s degree in a Scientific field with 3-5 years of validated experience in the areas of product registration, compliance, or quality systems; or a combination of education and experience determined to be equivalent.

Please refer the Job description for details