Staff Regulatory Affairs Specialist

BD (Becton, Dickinson and Company) • San Diego, CA

87d • $124,700 - $205,800

About The Position

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

• Minimum bachelor's degree in RA, QA, engineering, or other science-related discipline
• Advanced degree (e.g. MS, Life Sciences) preferred
• RAPS RAC certification preferred
• Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices
• Experience with end-to-end SAMD new product development, sustaining and end of life activities including experience on new labeling creation (including inputs on labeling specifications), risk management file review and inputs (including all documents required under risk files)
• Knowledge of global Regulatory Affairs requirements, regulations, and standards
• Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects
• Excellent interpersonal, communication, and analytical skills and able to partner with cross-functional colleagues to identify regulatory innovation

Responsibilities

• Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Problem solve and escalate regulatory and compliance issues to senior management as necessary
• Drive continuous improvement in internal processes and customer satisfaction
• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
• Support that QMS requirements are followed and executed consistently from RA perspective
• Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content
• Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level
• Assist in preparing, auditing, editing, and publishing registration documentation as needed
• Support business export control (BEC) listing of product for release globally per RA requirements
• Support the review and approval of product labeling, promotional, and advertising materials as needed.

Benefits

• Competitive salary range of $124,700.00 - $205,800.00 USD Annual
• On-site collaboration to foster creativity and innovation
• Flexibility and work-life balance
• Opportunities for professional development and recognition

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees