BD Mexico
Overview
BD is one of the largest global medical technology companies, advancing medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees with a presence in virtually every country to address global health issues. Join us to learn, grow, and become your best self. Responsibilities
Lead and develop direct report associates to ensure regulatory compliance Problem solve and escalate regulatory and compliance issues to senior management as vital Provide effective leadership, team development, clear communication, and quick responses to customers Drive continuous improvement in internal processes and customer satisfaction Identify, develop, and mentor impactful regulatory talent Author and organize regulatory submission content (510(k), Technical Files, etc.) Develop and implement global regulatory strategy for MMS Dispensing Medical Device and related software Lead regulatory efforts to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR) Monitor, interpret, and implement current and new regulatory requirements and international standards for U.S., EU, and RoW Ensure QMS requirements are followed and executed consistently from the RA perspective Oversee Technical File creation and remediation with cross-functional collaboration Support regulatory impact assessments for change controls and other RA/QA items Assist in preparing, auditing, editing, and publishing registration documentation as needed Support regulatory export control listing of products for global release per RA requirements Review and approve product labeling, promotional, and advertising materials as needed Perform other duties and assignments as required Qualifications
Bachelor’s degree in RA, QA, engineering, or another science-related discipline Advanced degree (e.g., MS, PhD) preferred RAPS RAC certification preferred Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field Minimum of 7 years of personnel management experience including performance evaluations and career development Software experience including SaMD/SiMD is a plus Regulatory and Quality Information Management systems experience (e.g., SAP, RIM) Digital literacy: MS Word, Excel, PowerPoint, Teams Project Management experience Knowledge of global Regulatory Affairs requirements, regulations and standards Experience authoring regulatory submissions (US and Global) Strong prioritizing, interpersonal, communication, and analytical skills with multi-tasking ability Ability to represent Regulatory Affairs in Marketing, R&D, and compliance environments and collaborate with all levels Ability to partner with cross-functional colleagues to identify opportunities for regulatory innovation Ability to read, analyze, and interpret regulatory literature and communicate findings clearly Ability to work in a team environment and independently with minimum supervision Identify and communicate risks and mitigations for global regulatory strategies to cross-functional collaborators Demonstrated leadership courage, openness to diverse views, candor, and willingness to make changes when needed Ability to travel globally up to 10% of the time Additional Information
For certain roles, employment is contingent on proof of full vaccination against COVID-19. Testing may be available or required in some locations. Accommodation requests will be considered under applicable law. Why Join Us
A career at BD values your opinions and contributions and supports your authentic self. We are committed to helping each other grow, do what’s right, hold each other accountable, and improve every day. Learn more about BD at the careers site. BD is an Equal Opportunity/Affirmative Action Employer. We do not discriminate on protected characteristics. Primary Work Location
USA CA - San Diego TC Bldg C&D Salary Range
$179,200.00 - $322,500.00 USD Annual BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on protected characteristics.
#J-18808-Ljbffr
BD is one of the largest global medical technology companies, advancing medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees with a presence in virtually every country to address global health issues. Join us to learn, grow, and become your best self. Responsibilities
Lead and develop direct report associates to ensure regulatory compliance Problem solve and escalate regulatory and compliance issues to senior management as vital Provide effective leadership, team development, clear communication, and quick responses to customers Drive continuous improvement in internal processes and customer satisfaction Identify, develop, and mentor impactful regulatory talent Author and organize regulatory submission content (510(k), Technical Files, etc.) Develop and implement global regulatory strategy for MMS Dispensing Medical Device and related software Lead regulatory efforts to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR) Monitor, interpret, and implement current and new regulatory requirements and international standards for U.S., EU, and RoW Ensure QMS requirements are followed and executed consistently from the RA perspective Oversee Technical File creation and remediation with cross-functional collaboration Support regulatory impact assessments for change controls and other RA/QA items Assist in preparing, auditing, editing, and publishing registration documentation as needed Support regulatory export control listing of products for global release per RA requirements Review and approve product labeling, promotional, and advertising materials as needed Perform other duties and assignments as required Qualifications
Bachelor’s degree in RA, QA, engineering, or another science-related discipline Advanced degree (e.g., MS, PhD) preferred RAPS RAC certification preferred Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field Minimum of 7 years of personnel management experience including performance evaluations and career development Software experience including SaMD/SiMD is a plus Regulatory and Quality Information Management systems experience (e.g., SAP, RIM) Digital literacy: MS Word, Excel, PowerPoint, Teams Project Management experience Knowledge of global Regulatory Affairs requirements, regulations and standards Experience authoring regulatory submissions (US and Global) Strong prioritizing, interpersonal, communication, and analytical skills with multi-tasking ability Ability to represent Regulatory Affairs in Marketing, R&D, and compliance environments and collaborate with all levels Ability to partner with cross-functional colleagues to identify opportunities for regulatory innovation Ability to read, analyze, and interpret regulatory literature and communicate findings clearly Ability to work in a team environment and independently with minimum supervision Identify and communicate risks and mitigations for global regulatory strategies to cross-functional collaborators Demonstrated leadership courage, openness to diverse views, candor, and willingness to make changes when needed Ability to travel globally up to 10% of the time Additional Information
For certain roles, employment is contingent on proof of full vaccination against COVID-19. Testing may be available or required in some locations. Accommodation requests will be considered under applicable law. Why Join Us
A career at BD values your opinions and contributions and supports your authentic self. We are committed to helping each other grow, do what’s right, hold each other accountable, and improve every day. Learn more about BD at the careers site. BD is an Equal Opportunity/Affirmative Action Employer. We do not discriminate on protected characteristics. Primary Work Location
USA CA - San Diego TC Bldg C&D Salary Range
$179,200.00 - $322,500.00 USD Annual BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on protected characteristics.
#J-18808-Ljbffr