BD
Job Title:
Senior Regulatory Affairs Specialist Location:
San Milpitas, CA Employment Type:
Full-time
BD Life Sciences is recruiting for a Senior Regulatory Affairs Specialist to prepare and approve regulatory submissions for new or modified in vitro diagnostic devices and research use only products globally. The role involves developing and managing processes to ensure regulatory compliance, coordinating documentation and submissions, and collaborating across functional teams.
Responsibilities
Manage regulatory processes with country RA partners and government agencies; coordinate submission package preparation; review documents and prepare correspondence.
Collaborate with Marketing, Sales, Technical Support and other internal functions to understand customer needs and improve product performance.
Monitor legislative changes, stay current on emerging trends and assess impact on operations.
Conduct audits to ensure compliance and implement corrective actions.
Collect safety and effectiveness data from R&D, Quality Control, Manufacturing; compile reports and present to management.
Coordinate testing procedures for finished goods; evaluate test results against regulatory criteria.
Provide regulatory guidance to other departments.
Required Skills & Experience
Minimum 5 years in regulatory affairs within a regulated industry (medical device, aerospace, automotive, pharmaceutical).
Strong analytical and critical thinking skills.
Excellent interpersonal and communication skills.
Ability to manage multiple projects and meet tight deadlines.
Proficiency in Microsoft Office Suite.
Preferred Skills & Experience
Bachelor’s degree in Science, Engineering, Pharmacy or equivalent; preferred but not required.
Medical device industry experience (preferred).
Bilingual – Chinese/Mandarin (beneficial).
Commitment to Diversity 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 status, disability, military eligibility, or other legally protected characteristics.
Work Shift: 1st Shift – 8:30 AM to 5:00 PM (United States)
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Senior Regulatory Affairs Specialist Location:
San Milpitas, CA Employment Type:
Full-time
BD Life Sciences is recruiting for a Senior Regulatory Affairs Specialist to prepare and approve regulatory submissions for new or modified in vitro diagnostic devices and research use only products globally. The role involves developing and managing processes to ensure regulatory compliance, coordinating documentation and submissions, and collaborating across functional teams.
Responsibilities
Manage regulatory processes with country RA partners and government agencies; coordinate submission package preparation; review documents and prepare correspondence.
Collaborate with Marketing, Sales, Technical Support and other internal functions to understand customer needs and improve product performance.
Monitor legislative changes, stay current on emerging trends and assess impact on operations.
Conduct audits to ensure compliance and implement corrective actions.
Collect safety and effectiveness data from R&D, Quality Control, Manufacturing; compile reports and present to management.
Coordinate testing procedures for finished goods; evaluate test results against regulatory criteria.
Provide regulatory guidance to other departments.
Required Skills & Experience
Minimum 5 years in regulatory affairs within a regulated industry (medical device, aerospace, automotive, pharmaceutical).
Strong analytical and critical thinking skills.
Excellent interpersonal and communication skills.
Ability to manage multiple projects and meet tight deadlines.
Proficiency in Microsoft Office Suite.
Preferred Skills & Experience
Bachelor’s degree in Science, Engineering, Pharmacy or equivalent; preferred but not required.
Medical device industry experience (preferred).
Bilingual – Chinese/Mandarin (beneficial).
Commitment to Diversity 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 status, disability, military eligibility, or other legally protected characteristics.
Work Shift: 1st Shift – 8:30 AM to 5:00 PM (United States)
#J-18808-Ljbffr