BD (Tissuemed Ltd)
Staff Regulatory Affairs Specialist
BD (Tissuemed Ltd), San Diego, California, United States, 92189
3 days ago Be among the first 25 applicants
Job Overview BD is one of the largest global medical technology companies. Advancing the world of health™ is our Purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing—to find transformative solutions.
Job Description Summary We are the makers of possible. Join us and discover an environment where you’ll be supported to learn, grow and become your best self.
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 monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and worldwide
Ensure QMS requirements are followed consistently from an RA perspective
Support Technical File creation, remediation, and collaboration with cross‑functional teams
Conduct regulatory impact assessments for change controls and other RA/QA items
Prepare, audit, edit, and publish registration documentation as needed
Manage business export control (BEC) listing of product for global release per RA requirements
Review and approve product labeling, promotional, and advertising materials
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 labeling creation and risk management file review
Knowledge of global Regulatory Affairs requirements, regulations, and standards
Strong prioritizing, interpersonal, communication, and analytical skills, and ability to multi‑task disparate projects
Excellent collaboration skills to partner with cross‑functional colleagues to identify regulatory innovation
Compensation & Benefits Salary: $124,700.00 – $205,800.00 USD Annual (based on experience, education, skills, and location). The offer may vary for field‑based and remote roles.
We offer a comprehensive benefits package, including health, dental, vision, life insurance, retirement contributions, and paid time off. Details are available through our Careers Site.
Workplace & Policies Minimum of 4 days in‑office presence per week for on‑site roles; remote or field‑based positions have flexible arrangements. Vaccination against COVID‑19 may be required. Accommodation requests will be considered in accordance with applicable law.
Why Join Us At BD, we value your opinions and contributions. We encourage authenticity, accountability, and continuous improvement. By joining our team, you can learn, grow, and help reinvent the future of health.
To learn more, visit
https://bd.com/careers
BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of protected status as described in the EEO statement.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Legal
Industries: Medical Equipment Manufacturing
Location: San Diego, CA (USA)
Primary Work Location: USA CA – San Diego TC Bldg C&D
Work Shift: Flexible (remote or on‑site)
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Job Overview BD is one of the largest global medical technology companies. Advancing the world of health™ is our Purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing—to find transformative solutions.
Job Description Summary We are the makers of possible. Join us and discover an environment where you’ll be supported to learn, grow and become your best self.
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 monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and worldwide
Ensure QMS requirements are followed consistently from an RA perspective
Support Technical File creation, remediation, and collaboration with cross‑functional teams
Conduct regulatory impact assessments for change controls and other RA/QA items
Prepare, audit, edit, and publish registration documentation as needed
Manage business export control (BEC) listing of product for global release per RA requirements
Review and approve product labeling, promotional, and advertising materials
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 labeling creation and risk management file review
Knowledge of global Regulatory Affairs requirements, regulations, and standards
Strong prioritizing, interpersonal, communication, and analytical skills, and ability to multi‑task disparate projects
Excellent collaboration skills to partner with cross‑functional colleagues to identify regulatory innovation
Compensation & Benefits Salary: $124,700.00 – $205,800.00 USD Annual (based on experience, education, skills, and location). The offer may vary for field‑based and remote roles.
We offer a comprehensive benefits package, including health, dental, vision, life insurance, retirement contributions, and paid time off. Details are available through our Careers Site.
Workplace & Policies Minimum of 4 days in‑office presence per week for on‑site roles; remote or field‑based positions have flexible arrangements. Vaccination against COVID‑19 may be required. Accommodation requests will be considered in accordance with applicable law.
Why Join Us At BD, we value your opinions and contributions. We encourage authenticity, accountability, and continuous improvement. By joining our team, you can learn, grow, and help reinvent the future of health.
To learn more, visit
https://bd.com/careers
BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of protected status as described in the EEO statement.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Legal
Industries: Medical Equipment Manufacturing
Location: San Diego, CA (USA)
Primary Work Location: USA CA – San Diego TC Bldg C&D
Work Shift: Flexible (remote or on‑site)
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