Senior Specialist, Regulatory Affairs - Hybrid

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

Job summary

An established industry player is seeking a Senior Specialist in Regulatory Affairs to join their innovative team in San Diego. This role involves supporting the development and compliance of medical and non-medical devices, ensuring adherence to global regulations. You will play a crucial part in enhancing internal processes and customer satisfaction while collaborating with cross-functional teams. With a strong emphasis on on-site collaboration, this position offers a dynamic work environment where your contributions will make a significant impact in healthcare. If you are passionate about regulatory affairs and ready to grow, this opportunity is for you.

Qualifications

• 5+ years of regulatory affairs experience in medical devices.
• Strong knowledge of global regulatory requirements and standards.

Responsibilities

• Ensure compliance with FDA Medical Device Regulations and EU-MDR.
• Conduct regulatory impact assessments for change controls.
• Prepare and publish registration documents.

Skills

Regulatory Affairs

Compliance Management

Analytical Skills

Communication Skills

Multitasking

Education

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

Advanced degree (preferred)

RAPS RAC certification (preferred)

Job description

Senior Specialist, Regulatory Affairs - Hybrid

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Job Description Summary

As a Sr. Specialist of Regulatory Affairs, you will support MMS Dispensing products, including Medical Devices, Non-Medical Devices, Software, and Accessories, globally from a Regulatory Affairs perspective. Your responsibilities will include new product development, sustaining, and end-of-life activities. Candidates must be able to work in our San Diego, CA office 4 days per week.

Job Responsibilities

• Ensure compliance with regulations such as FDA Medical Device Regulations and EU-MDR.
• Identify and escalate regulatory and compliance issues to senior management.
• Improve internal processes and enhance customer satisfaction.
• Monitor and interpret current and upcoming regulatory requirements and standards for the U.S. and Rest of World.
• Ensure consistent application of QMS requirements from a Regulatory Affairs perspective.
• Assist in Technical File creation, remediation, and collaborate with cross-functional teams.
• Conduct regulatory impact assessments for change controls and other RA/QA items.
• Prepare, audit, edit, and publish registration documents.
• Support global product listing and export control compliance.
• Review and approve product labeling, promotional, and advertising materials.

Candidate Requirements

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

Salary ranges from $121,100 to $199,800 USD annually, based on experience and location. BD values on-site collaboration, requiring a minimum of 4 days per week in the office, with flexible arrangements for remote roles. Employment is contingent upon proof of COVID-19 vaccination where applicable.

Why Join Us?

Join BD to be part of a team that values your contributions, supports your growth, and encourages innovation. Discover a culture of learning, collaboration, and making a difference in healthcare.