BD
Overview
Staff Regulatory Affairs Specialist - SaMD role at BD. Responsible for supporting MMS Dispensing products (Medical Devices and Non-Medical Devices) along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support includes 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. 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 Qualifications
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 experience on new labeling creation (including inputs on labeling specifications), risk management file review and inputs (including all documents required under risk files) 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 and Benefits
Salary ranges have been implemented to reward associates fairly and competitively, ranging from entry level to experts in their field, with varying ranges by location. 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. $124,700.00 - 205,897.00 USD Annual Work Location and Conditions
Primary Work Location: USA CA - San Diego TC Bldg C&D We prioritize on-site collaboration to foster creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office presence per week is expected. Remote or field-based positions will have different arrangements indicated in the job posting. For certain roles, employment is contingent upon proof of full vaccination against COVID-19, and testing may be required in some locations. BD’s Workplace Accommodations Policy applies where relevant. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports growth and accountability. BD aims to help you learn, grow and become your best self. 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, sexual orientation, gender identity or expression, genetics, disability, military status, or any other protected status.
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Staff Regulatory Affairs Specialist - SaMD role at BD. Responsible for supporting MMS Dispensing products (Medical Devices and Non-Medical Devices) along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support includes 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. 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 Qualifications
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 experience on new labeling creation (including inputs on labeling specifications), risk management file review and inputs (including all documents required under risk files) 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 and Benefits
Salary ranges have been implemented to reward associates fairly and competitively, ranging from entry level to experts in their field, with varying ranges by location. 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. $124,700.00 - 205,897.00 USD Annual Work Location and Conditions
Primary Work Location: USA CA - San Diego TC Bldg C&D We prioritize on-site collaboration to foster creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office presence per week is expected. Remote or field-based positions will have different arrangements indicated in the job posting. For certain roles, employment is contingent upon proof of full vaccination against COVID-19, and testing may be required in some locations. BD’s Workplace Accommodations Policy applies where relevant. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports growth and accountability. BD aims to help you learn, grow and become your best self. 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, sexual orientation, gender identity or expression, genetics, disability, military status, or any other protected status.
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