Associate Director Regulatory Affairs (hybrid) (San Diego)

Associate Director Regulatory Affairs (Hybrid)

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Job Overview

BD, one of the largest global medical technology companies, is seeking an Associate Director of Regulatory Affairs to support regulatory strategies for infusion technologies, including new product submissions, registration maintenance, and compliance documentation. This role offers a flexible work schedule, with 4 days onsite in San Diego and remote work on Fridays.

Key Responsibilities

• Lead regulatory submission activities and coordinate with cross-functional teams.
• Manage interactions with internal stakeholders and external regulators and consultants.
• Maintain documentation for compliance programs, including labeling and promotional materials.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Regulatory Affairs Certification (RAC) and Project Management Certification preferred.
• Minimum 10 years of relevant experience, including 5+ years in medical device regulatory affairs.
• Experience with external agencies and familiarity with infusion pump systems is advantageous.

Skills & Competencies

• Strong project management and organizational skills.
• Excellent communication skills and ability to handle multiple priorities.
• Proficiency in Microsoft Office.

Additional Information

BD emphasizes on-site collaboration but offers flexible arrangements. Employment may require COVID-19 vaccination proof or testing, per company policy. The salary range is $169,800 - $280,300 annually.