BD
Job Description Summary: As Staff Regulatory Affairs Specialist, 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.
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
Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU‑MDR).
Problem‑solve and elevate 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.
Ensure that QMS requirements are followed and executed consistently from a regulatory affairs 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.
Experience with end‑to‑end SAMD new product development, sustaining and end‑of‑life activities including labeling creation, risk management file review and inputs.
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 ability to partner with cross‑functional colleagues to identify regulatory innovation.
Salary Information $124,700.00 – 205,897.00 USD Annual
Location: USA, CA – San Diego. Minimum of 4 days of on‑site presence per week unless remote or field‑based arrangement is specified.
Vaccination: Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing may be available and/or required.
At BD, we prioritize on‑site collaboration and meet flexibility needs. We comply with Workplace Accommodations Policy.
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.
#J-18808-Ljbffr
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
Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU‑MDR).
Problem‑solve and elevate 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.
Ensure that QMS requirements are followed and executed consistently from a regulatory affairs 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.
Experience with end‑to‑end SAMD new product development, sustaining and end‑of‑life activities including labeling creation, risk management file review and inputs.
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 ability to partner with cross‑functional colleagues to identify regulatory innovation.
Salary Information $124,700.00 – 205,897.00 USD Annual
Location: USA, CA – San Diego. Minimum of 4 days of on‑site presence per week unless remote or field‑based arrangement is specified.
Vaccination: Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing may be available and/or required.
At BD, we prioritize on‑site collaboration and meet flexibility needs. We comply with Workplace Accommodations Policy.
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.
#J-18808-Ljbffr