Staff Regulatory Affairs Specialist - Hybrid

BD; Glendale (CA); On-site; USD 121,000 - 200,000; Full time

Job summary

An established industry player is seeking a Sr. Specialist in Regulatory Affairs to support Medical Devices and associated Software globally. This role involves ensuring compliance with FDA and EU regulations while driving process improvements and collaborating with cross-functional teams. The ideal candidate will have a strong background in Regulatory Affairs, excellent communication skills, and the ability to manage multiple projects effectively. Join a dynamic team that values creativity and innovation in the fast-paced healthcare sector, where your contributions will make a significant impact.

Qualifications

• 5+ years of experience in Regulatory Affairs/Compliance in medical devices.
• Knowledge of global Regulatory Affairs requirements and standards.

Responsibilities

• Support regulatory compliance with FDA and EU-MDR regulations.
• Drive continuous improvement in internal processes and customer satisfaction.

Skills

Regulatory Affairs

Compliance

Analytical Skills

Interpersonal Skills

Communication Skills

Problem Solving

Project Management

Education

Bachelor's degree in RA, QA, engineering, or science-related discipline

Advanced degree (e.g. MS, Life Sciences)

Tools

Technical File creation

Job description

Job Description Summary: As Sr. Specialist of Regulatory Affairs, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of 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.

Primary 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.

About You:

• 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
• 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

Salary Range Information:

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary: $121,100.00 - $199,800.00 USD Annual

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.