BD
Job Overview
Join to apply for the Senior Regulatory Affairs Specialist role at BD in San Milpitas, CA. The role includes preparing and approving regulatory submissions for new or modified in vitro diagnostic devices and research use only (RUO) products worldwide. Responsibilities
Manage the regulatory process by interacting with RA partners and government agencies, coordinating internal meetings, overseeing submission package preparation, reviewing drafts, preparing correspondence, responding to queries, liaising between departments and authorities, negotiating and resolving issues, ensuring timely decisions for commercialization globally. Collaborate closely with Marketing, Sales, Technical Support to understand customer needs, identify improvement opportunities, develop strategies for growth, leverage cross‑functional expertise. Monitor legislative changes, stay abreast of trends, maintain records, and devise plans to adapt business units, ensuring compliance and supporting operations. Conduct regular audits to ensure compliance with relevant regulations, identify gaps and implement corrective measures. Gather safety and effectiveness data with R&D, QC, Manufacturing, collate reports, present results to management, provide feedback. Coordinate testing procedures on finished goods before release, review protocols, evaluate results, determine compliance with criteria. Provide guidance and advice on regulatory affairs to other departments. Qualifications
Minimum 5 years’ experience in regulatory affairs in medical devices or regulated industries such as aerospace, automotive, pharmaceutical. Strong analytical, critical thinking and problem solving skills. Excellent interpersonal and relationship building skills. Clear verbal and written communication skills. Proven multi‑project management and meeting tight deadlines. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Preferred Skills
Bachelor’s degree in Science, Engineering, Pharmacy or equivalent, but not essential if sufficient experience. Experience in Medical Device industry preferred; other regulated industries considered. Bilingual Chinese/Mandarin beneficial. Benefits
BD supports collaboration, career growth, performance‑based compensation, and benefits. Remote or field‑based options available for certain roles. EEO Statement
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally‑protected characteristics.
#J-18808-Ljbffr
Join to apply for the Senior Regulatory Affairs Specialist role at BD in San Milpitas, CA. The role includes preparing and approving regulatory submissions for new or modified in vitro diagnostic devices and research use only (RUO) products worldwide. Responsibilities
Manage the regulatory process by interacting with RA partners and government agencies, coordinating internal meetings, overseeing submission package preparation, reviewing drafts, preparing correspondence, responding to queries, liaising between departments and authorities, negotiating and resolving issues, ensuring timely decisions for commercialization globally. Collaborate closely with Marketing, Sales, Technical Support to understand customer needs, identify improvement opportunities, develop strategies for growth, leverage cross‑functional expertise. Monitor legislative changes, stay abreast of trends, maintain records, and devise plans to adapt business units, ensuring compliance and supporting operations. Conduct regular audits to ensure compliance with relevant regulations, identify gaps and implement corrective measures. Gather safety and effectiveness data with R&D, QC, Manufacturing, collate reports, present results to management, provide feedback. Coordinate testing procedures on finished goods before release, review protocols, evaluate results, determine compliance with criteria. Provide guidance and advice on regulatory affairs to other departments. Qualifications
Minimum 5 years’ experience in regulatory affairs in medical devices or regulated industries such as aerospace, automotive, pharmaceutical. Strong analytical, critical thinking and problem solving skills. Excellent interpersonal and relationship building skills. Clear verbal and written communication skills. Proven multi‑project management and meeting tight deadlines. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Preferred Skills
Bachelor’s degree in Science, Engineering, Pharmacy or equivalent, but not essential if sufficient experience. Experience in Medical Device industry preferred; other regulated industries considered. Bilingual Chinese/Mandarin beneficial. Benefits
BD supports collaboration, career growth, performance‑based compensation, and benefits. Remote or field‑based options available for certain roles. EEO Statement
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally‑protected characteristics.
#J-18808-Ljbffr