BD (Tissuemed Ltd)
Staff Regulatory Affairs Specialist - SaMD
BD (Tissuemed Ltd), San Diego, California, United States, 92189
Staff Regulatory Affairs Specialist - SaMD
Join to apply for the
Staff Regulatory Affairs Specialist - SaMD
role at
BD (Tissuemed Ltd)
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.
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
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
$124,700.00 - 205,897.00 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.
Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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
Staff Regulatory Affairs Specialist - SaMD
role at
BD (Tissuemed Ltd)
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.
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
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
$124,700.00 - 205,897.00 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.
Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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