Regulatory Affairs Specialist II (Hybrid)

About the role

BD is one of the largest global medical technology companies, advancing the world of health through imagination and passion across design, engineering, manufacturing, and marketing of billions of MedTech products yearly. The Regulatory Affairs Specialist II is responsible for implementing regulatory strategies, supporting domestic and international submissions, and assisting product project teams throughout the product life cycle.

Responsibilities

• Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control, preparing submission related documents)
• Prepare and audit 510(k)s, IDEs, PMA 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
• Support CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
• May provide training or direction to other regulatory team members

Qualifications

• Knowledge of U.S. and European medical device regulations
• Excellent written and verbal communication skills
• Self‑motivated, able to work independently and take ownership of responsibilities
• Ability to prioritize and handle several projects concurrently
• Technical writing skills and proficiency compiling successful submissions for the appropriate audience
• Ability to provide leadership and mentoring to less experienced regulatory personnel
• Ability to maintain confidentiality with regulatory and clinical documentation
• BS in a scientific field with 3‑5 years experience in medical device product registration (or equivalent combination of education and experience)
• 2+ years regulatory support through the product life cycle on product project teams (developing strategies, timelines, change control, preparing submission documents)
• 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
• Experience supporting CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
• Previous experience training or directing other regulatory team members
• Regulatory Affairs Certification (RAC) desired
• Command of the English language
• Mathematical skills sufficient to describe and summarize laboratory and/or clinical data for product registration submissions
• Ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation
• Ability to operate computer and office equipment as needed; travel via airlines as needed
• Traditional office work environment

Benefits

BD emphasizes on‑site collaboration to foster creativity, innovation, and effective problem‑solving, while valuing flexibility and work‑life balance. The company offers a culture where employees can learn, grow, and thrive, with opportunities to connect in person for deeper collaboration and stronger culture.

Schedule

Work shift: 1st shift, 8:00 am – 4:30 pm, with a hybrid arrangement of four days on‑site and one day remote (Friday) per week in Covington, GA.