Staff Regulatory Affairs Specialist - Hybrid

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

Job summary

Join a forward-thinking company as a Sr. Specialist in Regulatory Affairs, where your expertise will support innovative medical and non-medical devices. In this dynamic role, you will ensure compliance with global regulations and standards while collaborating with cross-functional teams to drive product success. Your insights will help shape the future of health, as you contribute to the development and maintenance of essential medical technologies. This is an exciting opportunity to be part of a team that values creativity, accountability, and continuous improvement in a fast-paced environment.

Qualifications

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

Responsibilities

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

Skills

Regulatory Affairs

Compliance

Problem Solving

Interpersonal Skills

Analytical Skills

Communication Skills

Multi-tasking

Education

Bachelor’s Degree in RA, QA, Engineering, or Science

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

Tools

Technical File Creation

Quality Management Systems (QMS)

Job description

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.

Job Description

We are the makers of possible

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.

Primary Responsibilities:

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

About You:

1. Minimum bachelor’s degree in RA, QA, engineering, or other science-related discipline
2. Advanced degree (e.g. MS, Life Sciences) preferred
3. RAPS RAC certification preferred
4. Minimum of 5 years of strong Regulatory Affairs / Compliance experience in medical devices
5. Knowledge of global Regulatory Affairs requirements, regulations, and standards
6. Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects
7. Excellent interpersonal, communication, and analytical skills and able to partner with cross-functional colleagues to identify regulatory innovation

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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit

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.