Senior Specialist, Regulatory Affairs - Hybrid

BD; San Diego (CA); Hybrid; USD 121,000 - 200,000; Full time

Job summary

An established industry player in medical technology is seeking a Senior Specialist in Regulatory Affairs to join their dynamic team in San Diego. This pivotal role involves ensuring compliance with global regulatory standards and supporting new product development across various medical devices and software. The ideal candidate will possess strong analytical and communication skills and have a minimum of 5 years of experience in regulatory affairs. Join a forward-thinking company that values innovation and collaboration, and make a meaningful impact in the healthcare sector while enjoying a hybrid work model that promotes work-life balance.

Qualifications

• 5+ years of regulatory experience in medical devices.
• Strong communication and analytical skills are essential.

Responsibilities

• Ensure compliance with regulatory requirements like FDA and EU-MDR.
• Prepare and review registration documentation for medical devices.

Skills

Regulatory Compliance

Analytical Skills

Communication Skills

Multitasking

Knowledge of Global Regulatory Standards

Education

Bachelor’s degree in RA, QA, engineering, or related field

Advanced degree preferred

RAPS RAC certification preferred

Job description

Senior Specialist, Regulatory Affairs - Hybrid

Join us as a Senior Specialist, Regulatory Affairs - Hybrid at BD

Job Summary

As a Sr. Specialist in Regulatory Affairs, you will support MMS Dispensing products, including Medical Devices, Non-Medical Devices, Software, and Accessories, on a global scale. Your responsibilities will encompass new product development, sustaining existing products, and end-of-life activities. Candidates must be willing to work in our San Diego, CA office four days a week.

About BD

BD is one of the world's leading medical technology companies, committed to advancing healthcare. We foster an environment of innovation, collaboration, and growth, aiming to transform healthcare and improve lives worldwide.

Primary Responsibilities

• Ensure compliance with regulatory requirements (e.g., FDA, EU-MDR)
• Identify and escalate regulatory issues to management
• Improve internal processes and customer satisfaction
• Monitor and interpret current and new regulations and standards globally
• Ensure adherence to Quality Management System (QMS) requirements
• Assist in Technical File creation and cross-functional collaboration
• Support regulatory impact assessments for change controls
• Prepare and review registration documentation
• Support global product listing and export controls
• Review product labeling and promotional materials

Qualifications

• Bachelor’s degree in RA, QA, engineering, or related field; advanced degree preferred
• RAPS RAC certification preferred
• Minimum 5 years of regulatory experience in medical devices
• Knowledge of global regulatory standards
• Strong communication, analytical, and multitasking skills

Compensation and Benefits

Salary ranges from $121,100 to $199,800 annually, based on experience and location. We prioritize on-site collaboration with a minimum of 4 days per week in the office, supporting work-life balance and flexibility.

Why Join Us?

Be part of a team that values your contributions, encourages growth, and strives to make a difference in healthcare. Discover a culture of learning, innovation, and purpose at BD.

Additional Information

Location: San Diego, CA. Employment is contingent upon proof of COVID-19 vaccination, with accommodations considered as per policy.