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Regulatory Affairs Associate at RIVERPOINT MEDICAL LLC
Portland, Oregon, United States - Full Time
Skills Needed
Regulatory Submissions, Fda 510(k), Eu Mdr, Technical Documentation, Risk Analysis, Customer Service, Quality System, Clinical Evaluation, Post Market Surveillance, Product Labeling, Scientific Rationale, Regulatory Requirements, Medical Devices, Iso13485, Mdsap
Specialization
Candidates should have 1-5 years of experience in Regulatory Affairs related to medical devices and a solid understanding of relevant regulations. The ability to create technical dossiers and assess project risks is essential.
Experience Required
Minimum 2 year(s)
Med Tech at Phoenix Senior Living
, Virginia, United States - Full Time
Skills Needed
Medication Administration, Resident Care, Clinical Quality Assurance, Leadership, Communication, Assessment, Dementia Care, Vital Signs Monitoring, Wellness Support, Documentation, Personalized Service Plan, Assisted Living, Change Management, Team Support, Elder Care, Flexible Hours
Specialization
Candidates must be certified Medication Aides and have at least one year of experience working with elders or disabled individuals. Leadership capabilities and knowledge in Assisted Living and Dementia care are preferred.
Schichtleiter:in Verpackung at Ankerbrot
Lichtenwörth, Lower Austria, Austria - Full Time
Skills Needed
Team Leadership, Hygiene Knowledge, Product Safety, Food Production Experience, Quality Control, Process Coordination, Employee Training, Reliability, Self Management, Responsibility, Time Management
Specialization
Candidates should have experience in employee leadership and a basic understanding of hygiene and product safety. Experience in food production is preferred, along with a strong sense of responsibility and teamwork.
Experience Required
Minimum 2 year(s)
Merchandiser/Auditor Position Available - Leitchfield KY at CCMI
Leitchfield, Kentucky, United States - Full Time
Skills Needed
Independent Work, Following Instructions, Photo Taking, Uploading Reports, Strong Work Ethic, Punctuality, Reliable Transportation, Face To Face Interaction, Part Time Availability, Supervision, Email Communication, Timely Responses, Accurate Task Completion
Specialization
Candidates should work well independently and follow written instructions precisely. Reliable transportation and a strong work ethic are essential, along with the ability to handle face-to-face interactions.
WELDER II at ANDERSON DAHLEN INC
Ramsey, Minnesota, United States - Full Time
Skills Needed
Welding, Layout, Cutting, Brazing, Soldering, Blueprint Reading, Math Skills, Hand Tools, Measuring Instruments, Welding Equipment Operation, Fixturing, Rigging, Gmaw, Gtaw, Fcaw, Quality Standards
Specialization
Candidates must have at least 3 years of welding experience and qualifications per ASME Section IX and/or AWS D1.1. Strong math skills and the ability to read blueprints are also required.
Experience Required
Minimum 2 year(s)
Premier Acquisition Manager-Sales-Sales at Kotak Mahindra Bank
Mumbai, maharashtra, India - Full Time
Skills Needed
Relationship Management, Customer Engagement, Portfolio Management, Coordination Skills, Customer Centric Approach
Specialization
The candidate should possess strong coordination skills and a customer-centric approach. Prior experience in portfolio management is also required.
Experience Required
Minimum 2 year(s)
Maintenance Mechanic at Dexterra Group Inc
Washington, District of Columbia, United States - Full Time
Skills Needed
Hvac, Plumbing, Electrical Systems, Troubleshooting, Preventative Maintenance, Carpentry, Communication Skills, Heavy Lifting, Forklift Operation, Safety Compliance, Diagnostics, Repair Services, Teamwork, Operational Excellence, Accountability
Specialization
Candidates must possess at least 5 years of recent experience in maintenance and repair of complex systems. They must also have the necessary registrations, certifications, and licenses, along with good communication skills.
Experience Required
Minimum 5 year(s)
Fresh Food Coordinator - Retail at Love's Travel Stops & Country Stores
, Missouri, United States - Full Time
Skills Needed
Food Safety, Sanitation, Task Execution, Team Coaching, Inventory Management, Ordering Supplies, Waste Reduction, Pricing, Promotions, Profitability Analysis, Lifting 25+ Pounds, Temperature Tolerance, Cross Training
Specialization
Candidates must be able to ensure a safe, clean kitchen environment and assist the Fresh Food Manager with task execution while following safety practices. Essential physical requirements include the ability to move and lift 25+ pounds and work in various temperatures, with potential for cross-training in other departments.
Healthy Living Coach Assistant at Holbrook Life Management- Woods
Acworth, Georgia, United States - Full Time
Skills Needed
Customer Service, Communication, Organization, Exercise Science, Group Fitness, Personal Training, Cpr Certification, First Aid Certification, Time Management, Detail Orientation, Marketing, Team Collaboration, Problem Solving, Software Proficiency, Health Education, Event Coordination
Specialization
Candidates must be at least 21 years old, possess a high school diploma or equivalent, and be pursuing a degree in Exercise Science or a related field. Current certifications in Group Fitness or Personal Training and CPR/First Aid are also required.
RN POOL TIER II Float Pool FCCC at Temple Health System
Philadelphia, Pennsylvania, United States - Full Time
Skills Needed
Patient Care, Nursing Process, Collaboration, Assessment, Implementation, Evaluation, Communication, Teamwork, Leadership, Clinical Specialty, Nursing Practice, Patient Advocacy, Family Support, Administrative Policies, Procedures, Basic Life Support
Specialization
Candidates must be graduates of an accredited school of nursing and hold a Bachelor's Degree. A PA Registered Nurse License and Basic Life Support certification are required, along with 2 years of experience in a clinical specialty preferred.
Experience Required
Minimum 2 year(s)
Director of Engineering (Service Foundations) at Databricks Canada ULC
Bengaluru, karnataka, India - Full Time
Skills Needed
Distributed Systems, Infrastructure Management, Cloud Infrastructure, Team Leadership, Technical Architecture, Software Engineering, Ai Integration, Scalability, Automation, Mentorship, Communication, Prioritization, Observability, Storage, Orchestration, Developer Platforms
Specialization
Candidates should have 20+ years of experience in building and operating large-scale distributed systems and a proven ability to manage high-performing infrastructure teams. A BS in Computer Science is required, with a Masters or PhD preferred.
Experience Required
Minimum 10 year(s)
Virtual Customer Sales Representative at Legacy Harbor Advisors
Nashville, Tennessee, United States - Full Time
Skills Needed
Self Motivated, Goal Oriented, Strong Communicators, Entrepreneurial Mindsets, Sales Techniques, Financial Products, Client Relationships, Crm Tools
Specialization
Candidates should be self-motivated and goal-oriented, thriving independently in a remote environment. Strong communication skills and an entrepreneurial mindset are essential for success in this role.
Virtual Customer Sales Representative at Legacy Harbor Advisors
Plano, Texas, United States - Full Time
Skills Needed
Self Motivated, Goal Oriented, Strong Communicators, Entrepreneurial Mindsets, Sales Techniques, Financial Products, Client Relationships, Crm Tools
Specialization
Candidates should be self-motivated and goal-oriented professionals who can thrive independently. Strong communication skills and an entrepreneurial mindset driven by results are essential.
Building Inspector at WESTWARD360 ASSOCIATION MANAGEMENT LLC
Chicago, Illinois, United States - Full Time
Skills Needed
Property Inspections, Documentation, Maintenance Issues, Inspection Software, Key Management, Communication, Time Management, Tech Savvy
Specialization
Candidates need 2+ years of experience in homeowner association management or maintenance. A valid driver's license and reliable transportation are also required.
Experience Required
Minimum 2 year(s)
Training Specialist II at Allegis Global Solutions
Manila, Metro Manila, Philippines - Full Time
Skills Needed
Training Delivery, Virtual Training Software, Microsoft Office Suite, Mentoring, Communication Skills, Collaboration, Engagement, Talent Development, Situational Adaptability, Planning, Logistics Coordination, Feedback, Content Development, Stakeholder Management, Event Coordination, Attendance Tracking
Specialization
Candidates should have 3 to 7 years of relevant training experience and proficiency in virtual training software and Microsoft Office. Strong communication skills and the ability to mentor new team members are also essential.
Experience Required
Minimum 5 year(s)
Part-Time Security Guard, Legacy House Supportive Housing at CAMBA
New York, New York, United States - Full Time
Skills Needed
Access Control, Traffic Management, Fire Prevention, Vandalism Detection, Theft Prevention, Rule Enforcement, Observation Skills, Reporting Skills, Client Protection, Visitor Assistance
Specialization
Candidates must have a high school diploma or G.E.D. and complete various security training courses, including obtaining a NYS Security Guard license and Fire Guard certification.
Customer Service Representative at SB Clinical Practice Management
Town of Brookhaven, New York, United States - Full Time
Skills Needed
Customer Service, Appointment Scheduling, Insurance Verification, Communication Skills, Organizational Skills, Typing Skills, Problem Solving, Analytical Skills, Microsoft Office, Medical Terminology, Bilingual, Telephone Etiquette
Specialization
A high school diploma or GED is required, along with strong organizational and communication skills. Preferred qualifications include clerical experience, experience in a physician practice, and proficiency in Microsoft Office.
Warehouse Clerk - Shakopee MN at Temco Logistics
Shakopee, Minnesota, United States - Full Time
Skills Needed
Order Pulling, Attention To Detail, Quality Inspection, Heavy Equipment Operation, Forklift Operation, Rf Scanners, Physical Stamina, Fast Paced Environment, Problem Solving, Teamwork, Time Management, Communication, Organization, Loading And Unloading, Shrink Wrapping, Inventory Management
Specialization
Candidates should have at least 1 year of experience in a warehouse role and the ability to operate heavy equipment like forklifts. Attention to detail and physical stamina are essential for success in this fast-paced environment.
Store Associate - G2G at GOOD 2 GO STORES LLC
Socorro, New Mexico, United States - Full Time
Skills Needed
Customer Service, Cash Management, Inventory Management, Multitasking, Sales, Charisma, Teamwork, Communication
Specialization
Candidates should be able to stand for extended periods and perform various physical tasks, including lifting up to 25 lbs. A strong customer service focus and the ability to multitask are essential.
Entry Level Mortgage Customer Service Rep at Teksystems Global Services LLC
Tempe, Arizona, United States - Full Time
Skills Needed
Customer Service, Mortgage Servicing, Escrow, Payment Processing, Refinancing Opportunities, Outbound Calling, Website Assistance, Positive Attitude, Courtesy, Helpfulness, Dynamic Routing, Engagement, Communication, Problem Solving, Time Management, Bilingual Skills
Specialization
This is an entry-level position, so no specific experience is required, but candidates should demonstrate positivity and helpfulness. Bilingual candidates are preferred, especially those who speak Spanish.
Regulatory Affairs Associate at RIVERPOINT MEDICAL LLC
Portland, Oregon, United States -
Full Time

Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

0.0

Posted On

15 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Submissions, FDA 510(k), EU MDR, Technical Documentation, Risk Analysis, Customer Service, Quality System, Clinical Evaluation, Post-market Surveillance, Product Labeling, Scientific Rationale, Regulatory Requirements, Medical Devices, ISO13485, MDSAP

Industry

Medical Equipment Manufacturing

Description
Riverpoint Medical in Northeast Portland is hiring for Regulatory Affairs Associate. This position will be onsite at our new office, The Point. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies.    Duties and Responsibilities: * Identify and prepare regulatory submissions for approval, FDA 510(k), EU MDR/CE, and other international markets. * Maintain Establishment Registrations, Device Listings and State Licenses both Domestic and International. * Prepare and submit regulatory notices and notifications for post market surveillance and vigilance.  * Collaborate with customers to create and maintain technical documentation for regulatory submissions. * Generate annual medical device management review annual reports. * Ensure the appropriateness of regulatory standards referenced within Quality System, maintain updated standard library and conduct GAP/risk analysis to determine impact of standard changes/revisions to comply with the state of the art. * Review and approve Clinical Evaluation, Post-market Surveillance, and Post Market Clinical Follow-up reports. * Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products. * Review quality documents (operational procedures, work instructions, validations, etc.) including but not limited to protocols, for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development strategy. * Make quality regulatory decisions, balancing risks, and benefits. Qualifications:  * Minimum 1-5 years’ knowledge and experience in Regulatory Affairs in the manufacture of medical devices. * Understanding of FDA QSR (21 CRF 820), MDR, ISO13485, and MDSAP.  * Ability to create technical dossiers for customer regulatory submissions. * The ability to interpret regulations, guidance and correctly apply them as appropriate in product development. * Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval. * Ability to review detailed scientific information and assess whether technical justifications are presented clearly, and conclusions are adequately supported by data. * Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. * Customer Centric attitude, and experience with customer service is preferred   We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus!    Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.   
Responsibilities
The Regulatory Affairs Associate will identify and prepare regulatory submissions for various markets, including FDA and EU. They will also maintain regulatory documentation and collaborate with customers to ensure compliance with standards.
Regulatory Affairs Associate at RIVERPOINT MEDICAL LLC
Portland, Oregon, United States - Full Time
Skills Needed
Regulatory Submissions, Fda 510(k), Eu Mdr, Technical Documentation, Risk Analysis, Customer Service, Quality System, Clinical Evaluation, Post Market Surveillance, Product Labeling, Scientific Rationale, Regulatory Requirements, Medical Devices, Iso13485, Mdsap
Specialization
Candidates should have 1-5 years of experience in Regulatory Affairs related to medical devices and a solid understanding of relevant regulations. The ability to create technical dossiers and assess project risks is essential.
Experience Required
Minimum 2 year(s)
Med Tech at Phoenix Senior Living
, Virginia, United States - Full Time
Skills Needed
Medication Administration, Resident Care, Clinical Quality Assurance, Leadership, Communication, Assessment, Dementia Care, Vital Signs Monitoring, Wellness Support, Documentation, Personalized Service Plan, Assisted Living, Change Management, Team Support, Elder Care, Flexible Hours
Specialization
Candidates must be certified Medication Aides and have at least one year of experience working with elders or disabled individuals. Leadership capabilities and knowledge in Assisted Living and Dementia care are preferred.
Schichtleiter:in Verpackung at Ankerbrot
Lichtenwörth, Lower Austria, Austria - Full Time
Skills Needed
Team Leadership, Hygiene Knowledge, Product Safety, Food Production Experience, Quality Control, Process Coordination, Employee Training, Reliability, Self Management, Responsibility, Time Management
Specialization
Candidates should have experience in employee leadership and a basic understanding of hygiene and product safety. Experience in food production is preferred, along with a strong sense of responsibility and teamwork.
Experience Required
Minimum 2 year(s)
Merchandiser/Auditor Position Available - Leitchfield KY at CCMI
Leitchfield, Kentucky, United States - Full Time
Skills Needed
Independent Work, Following Instructions, Photo Taking, Uploading Reports, Strong Work Ethic, Punctuality, Reliable Transportation, Face To Face Interaction, Part Time Availability, Supervision, Email Communication, Timely Responses, Accurate Task Completion
Specialization
Candidates should work well independently and follow written instructions precisely. Reliable transportation and a strong work ethic are essential, along with the ability to handle face-to-face interactions.
WELDER II at ANDERSON DAHLEN INC
Ramsey, Minnesota, United States - Full Time
Skills Needed
Welding, Layout, Cutting, Brazing, Soldering, Blueprint Reading, Math Skills, Hand Tools, Measuring Instruments, Welding Equipment Operation, Fixturing, Rigging, Gmaw, Gtaw, Fcaw, Quality Standards
Specialization
Candidates must have at least 3 years of welding experience and qualifications per ASME Section IX and/or AWS D1.1. Strong math skills and the ability to read blueprints are also required.
Experience Required
Minimum 2 year(s)
Premier Acquisition Manager-Sales-Sales at Kotak Mahindra Bank
Mumbai, maharashtra, India - Full Time
Skills Needed
Relationship Management, Customer Engagement, Portfolio Management, Coordination Skills, Customer Centric Approach
Specialization
The candidate should possess strong coordination skills and a customer-centric approach. Prior experience in portfolio management is also required.
Experience Required
Minimum 2 year(s)
Maintenance Mechanic at Dexterra Group Inc
Washington, District of Columbia, United States - Full Time
Skills Needed
Hvac, Plumbing, Electrical Systems, Troubleshooting, Preventative Maintenance, Carpentry, Communication Skills, Heavy Lifting, Forklift Operation, Safety Compliance, Diagnostics, Repair Services, Teamwork, Operational Excellence, Accountability
Specialization
Candidates must possess at least 5 years of recent experience in maintenance and repair of complex systems. They must also have the necessary registrations, certifications, and licenses, along with good communication skills.
Experience Required
Minimum 5 year(s)
Fresh Food Coordinator - Retail at Love's Travel Stops & Country Stores
, Missouri, United States - Full Time
Skills Needed
Food Safety, Sanitation, Task Execution, Team Coaching, Inventory Management, Ordering Supplies, Waste Reduction, Pricing, Promotions, Profitability Analysis, Lifting 25+ Pounds, Temperature Tolerance, Cross Training
Specialization
Candidates must be able to ensure a safe, clean kitchen environment and assist the Fresh Food Manager with task execution while following safety practices. Essential physical requirements include the ability to move and lift 25+ pounds and work in various temperatures, with potential for cross-training in other departments.
Healthy Living Coach Assistant at Holbrook Life Management- Woods
Acworth, Georgia, United States - Full Time
Skills Needed
Customer Service, Communication, Organization, Exercise Science, Group Fitness, Personal Training, Cpr Certification, First Aid Certification, Time Management, Detail Orientation, Marketing, Team Collaboration, Problem Solving, Software Proficiency, Health Education, Event Coordination
Specialization
Candidates must be at least 21 years old, possess a high school diploma or equivalent, and be pursuing a degree in Exercise Science or a related field. Current certifications in Group Fitness or Personal Training and CPR/First Aid are also required.
RN POOL TIER II Float Pool FCCC at Temple Health System
Philadelphia, Pennsylvania, United States - Full Time
Skills Needed
Patient Care, Nursing Process, Collaboration, Assessment, Implementation, Evaluation, Communication, Teamwork, Leadership, Clinical Specialty, Nursing Practice, Patient Advocacy, Family Support, Administrative Policies, Procedures, Basic Life Support
Specialization
Candidates must be graduates of an accredited school of nursing and hold a Bachelor's Degree. A PA Registered Nurse License and Basic Life Support certification are required, along with 2 years of experience in a clinical specialty preferred.
Experience Required
Minimum 2 year(s)
Director of Engineering (Service Foundations) at Databricks Canada ULC
Bengaluru, karnataka, India - Full Time
Skills Needed
Distributed Systems, Infrastructure Management, Cloud Infrastructure, Team Leadership, Technical Architecture, Software Engineering, Ai Integration, Scalability, Automation, Mentorship, Communication, Prioritization, Observability, Storage, Orchestration, Developer Platforms
Specialization
Candidates should have 20+ years of experience in building and operating large-scale distributed systems and a proven ability to manage high-performing infrastructure teams. A BS in Computer Science is required, with a Masters or PhD preferred.
Experience Required
Minimum 10 year(s)
Virtual Customer Sales Representative at Legacy Harbor Advisors
Nashville, Tennessee, United States - Full Time
Skills Needed
Self Motivated, Goal Oriented, Strong Communicators, Entrepreneurial Mindsets, Sales Techniques, Financial Products, Client Relationships, Crm Tools
Specialization
Candidates should be self-motivated and goal-oriented, thriving independently in a remote environment. Strong communication skills and an entrepreneurial mindset are essential for success in this role.
Virtual Customer Sales Representative at Legacy Harbor Advisors
Plano, Texas, United States - Full Time
Skills Needed
Self Motivated, Goal Oriented, Strong Communicators, Entrepreneurial Mindsets, Sales Techniques, Financial Products, Client Relationships, Crm Tools
Specialization
Candidates should be self-motivated and goal-oriented professionals who can thrive independently. Strong communication skills and an entrepreneurial mindset driven by results are essential.
Building Inspector at WESTWARD360 ASSOCIATION MANAGEMENT LLC
Chicago, Illinois, United States - Full Time
Skills Needed
Property Inspections, Documentation, Maintenance Issues, Inspection Software, Key Management, Communication, Time Management, Tech Savvy
Specialization
Candidates need 2+ years of experience in homeowner association management or maintenance. A valid driver's license and reliable transportation are also required.
Experience Required
Minimum 2 year(s)
Training Specialist II at Allegis Global Solutions
Manila, Metro Manila, Philippines - Full Time
Skills Needed
Training Delivery, Virtual Training Software, Microsoft Office Suite, Mentoring, Communication Skills, Collaboration, Engagement, Talent Development, Situational Adaptability, Planning, Logistics Coordination, Feedback, Content Development, Stakeholder Management, Event Coordination, Attendance Tracking
Specialization
Candidates should have 3 to 7 years of relevant training experience and proficiency in virtual training software and Microsoft Office. Strong communication skills and the ability to mentor new team members are also essential.
Experience Required
Minimum 5 year(s)
Part-Time Security Guard, Legacy House Supportive Housing at CAMBA
New York, New York, United States - Full Time
Skills Needed
Access Control, Traffic Management, Fire Prevention, Vandalism Detection, Theft Prevention, Rule Enforcement, Observation Skills, Reporting Skills, Client Protection, Visitor Assistance
Specialization
Candidates must have a high school diploma or G.E.D. and complete various security training courses, including obtaining a NYS Security Guard license and Fire Guard certification.
Customer Service Representative at SB Clinical Practice Management
Town of Brookhaven, New York, United States - Full Time
Skills Needed
Customer Service, Appointment Scheduling, Insurance Verification, Communication Skills, Organizational Skills, Typing Skills, Problem Solving, Analytical Skills, Microsoft Office, Medical Terminology, Bilingual, Telephone Etiquette
Specialization
A high school diploma or GED is required, along with strong organizational and communication skills. Preferred qualifications include clerical experience, experience in a physician practice, and proficiency in Microsoft Office.
Warehouse Clerk - Shakopee MN at Temco Logistics
Shakopee, Minnesota, United States - Full Time
Skills Needed
Order Pulling, Attention To Detail, Quality Inspection, Heavy Equipment Operation, Forklift Operation, Rf Scanners, Physical Stamina, Fast Paced Environment, Problem Solving, Teamwork, Time Management, Communication, Organization, Loading And Unloading, Shrink Wrapping, Inventory Management
Specialization
Candidates should have at least 1 year of experience in a warehouse role and the ability to operate heavy equipment like forklifts. Attention to detail and physical stamina are essential for success in this fast-paced environment.
Store Associate - G2G at GOOD 2 GO STORES LLC
Socorro, New Mexico, United States - Full Time
Skills Needed
Customer Service, Cash Management, Inventory Management, Multitasking, Sales, Charisma, Teamwork, Communication
Specialization
Candidates should be able to stand for extended periods and perform various physical tasks, including lifting up to 25 lbs. A strong customer service focus and the ability to multitask are essential.
Entry Level Mortgage Customer Service Rep at Teksystems Global Services LLC
Tempe, Arizona, United States - Full Time
Skills Needed
Customer Service, Mortgage Servicing, Escrow, Payment Processing, Refinancing Opportunities, Outbound Calling, Website Assistance, Positive Attitude, Courtesy, Helpfulness, Dynamic Routing, Engagement, Communication, Problem Solving, Time Management, Bilingual Skills
Specialization
This is an entry-level position, so no specific experience is required, but candidates should demonstrate positivity and helpfulness. Bilingual candidates are preferred, especially those who speak Spanish.