BD (Tissuemed Ltd)
Staff Regulatory Affairs Specialist
BD (Tissuemed Ltd), San Diego, California, United States, 92189
Staff Regulatory Affairs Specialist
BD (Tissuemed Ltd)
Location:
USA CA - San Diego TC Bldg C&D
Salary:
$124,700.00 - $205,800.00 USD Annual
Employment type:
Full-time
Seniority level:
Mid-Senior level
Job Overview As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non‑medical devices, medical devices, associated software, and accessories on a global scale.
Key Responsibilities
Support regulatory efforts to comply with new and existing US and international regulations and directives (e.g., FDA Medical Device Regulations, EU Low Voltage Directive, EU Electromagnetic Compatibility Directive, etc.).
Problem‑solve and Escalate regulatory and compliance issues to senior management as necessary. Drive continuous improvement in internal processes and customer satisfaction.
Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other regions. Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs 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 Regulatory Affairs/Quality Assurance items from a review and approval level.
Assist in preparing, auditing, editing, and publishing registration documentation as needed. Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements.
Review and approve labels, labeling, and promotional materials to ensure regulatory compliance. Assist in the collection of regulatory intelligence for projects related to US and international labeling remediation.
Perform gap analysis to support labeling projects and remediation activities. Remain current on standards and regulations affecting advertising, promotion, and labeling, and communicate the impact cross‑functionally.
Education
Bachelor’s degree required with a focus in Life Sciences or Engineering. An advanced degree (e.g., MS, Life Sciences) is preferred.
Certifications
RAPS RAC certification is preferred.
Experience
Minimum of five (5) years of Regulatory Affairs experience in the medical device industry required.
Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi‑task disparate projects required.
Knowledge of global Regulatory Affairs requirements, regulations, and standards strongly preferred.
Demonstrated ability to partner with cross‑functional colleagues to identify regulatory innovations required.
Familiarity with advertising, promotion, and labeling in the medical device industry is desired.
Additional Information For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence. Remote or field‑based positions will have different workplace arrangements indicated in the job posting.
Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. Requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, hold each other accountable, and learn and improve every day.
To learn more, visit https://bd.com/careers
Equal Opportunity 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.
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Location:
USA CA - San Diego TC Bldg C&D
Salary:
$124,700.00 - $205,800.00 USD Annual
Employment type:
Full-time
Seniority level:
Mid-Senior level
Job Overview As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non‑medical devices, medical devices, associated software, and accessories on a global scale.
Key Responsibilities
Support regulatory efforts to comply with new and existing US and international regulations and directives (e.g., FDA Medical Device Regulations, EU Low Voltage Directive, EU Electromagnetic Compatibility Directive, etc.).
Problem‑solve and Escalate regulatory and compliance issues to senior management as necessary. Drive continuous improvement in internal processes and customer satisfaction.
Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other regions. Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs 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 Regulatory Affairs/Quality Assurance items from a review and approval level.
Assist in preparing, auditing, editing, and publishing registration documentation as needed. Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements.
Review and approve labels, labeling, and promotional materials to ensure regulatory compliance. Assist in the collection of regulatory intelligence for projects related to US and international labeling remediation.
Perform gap analysis to support labeling projects and remediation activities. Remain current on standards and regulations affecting advertising, promotion, and labeling, and communicate the impact cross‑functionally.
Education
Bachelor’s degree required with a focus in Life Sciences or Engineering. An advanced degree (e.g., MS, Life Sciences) is preferred.
Certifications
RAPS RAC certification is preferred.
Experience
Minimum of five (5) years of Regulatory Affairs experience in the medical device industry required.
Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi‑task disparate projects required.
Knowledge of global Regulatory Affairs requirements, regulations, and standards strongly preferred.
Demonstrated ability to partner with cross‑functional colleagues to identify regulatory innovations required.
Familiarity with advertising, promotion, and labeling in the medical device industry is desired.
Additional Information For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence. Remote or field‑based positions will have different workplace arrangements indicated in the job posting.
Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. Requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, hold each other accountable, and learn and improve every day.
To learn more, visit https://bd.com/careers
Equal Opportunity 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.
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