BD Nogales Norte
Staff Regulatory Affairs Specialist - SaMD
BD Nogales Norte, San Diego, California, United States, 92189
Staff Regulatory Affairs Specialist - SaMD
Location: San Diego, CA. In-office 4 days per week. Base pay range: $121,100.00/yr - $205,897.00/yr Overview
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. 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 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 able to partner with cross-functional colleagues to identify regulatory innovation Salary information: Salary ranges may vary by location and other factors. The base pay range shown is for the role and location; actual offer may differ based on experience, education, skills, and work location. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days of in-office presence per week is required to maintain our culture of excellence. Remote or field-based roles will have different workplace arrangements indicated in the job posting. 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. BD 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
Location: San Diego, CA. In-office 4 days per week. Base pay range: $121,100.00/yr - $205,897.00/yr Overview
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. 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 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 able to partner with cross-functional colleagues to identify regulatory innovation Salary information: Salary ranges may vary by location and other factors. The base pay range shown is for the role and location; actual offer may differ based on experience, education, skills, and work location. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days of in-office presence per week is required to maintain our culture of excellence. Remote or field-based roles will have different workplace arrangements indicated in the job posting. 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. BD 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