Top 30 Senior qa specialist Jobs in Irvine, Ca

Sr Regulatory Affairs Specialist
Masimo —Irvine, CA
- $85,000 - $130,000 a year
- Full-time
- Microsoft Outlook
- Computer literacy
- Mid-level
- Paid parental leave
- AD&D insurance
Sr. Quality Engineer II / Sr. Quality Specialist II
Glaukos —San Clemente, CA
- $107,700 - $134,600 a year
- Full-time
- Background check
- Engineering
- Pass drug screening
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Supervisor, Enrollment Quality Assurance
SCAN Health Plan —Long Beach, CA
- $71,700 - $103,732 a year
- Full-time
- Hybrid work
- Background check
- Microsoft Excel
- Microsoft Outlook
- Wellness program
- Paid holidays
Quick Apply
6d
Senior Fire Protection Specialist - Aviation & Federal (California Region)
Burns & McDonnell —Brea, CA
- $150,000 - $210,000 a year
- Full-time
- System design
- Analysis skills
- Quality control
- 401(k)
- Employee stock ownership plan
Paid Social Specialist (Contractor) | Remote (US)
Blizzard Entertainment —Irvine, CA
- $57,020 - $105,480 a year
- Email
- Remote
- Microsoft Excel
- 5 years
- Analysis skills
- Health savings account
- AD&D insurance
Senior SEO Specialist – Local & Content
Do It Right Plumbers Inc. —Santa Ana, CA
- $2,000 - $3,500 a month
- Full-time
- Remote
- English
- Residential
- Senior level
Quick Apply
Senior Air Quality Specialist, Technical Leader
Ascent Environmental —Irvine, CA
- $120,000 - $150,000 a year
- Full-time
- Office
- 8 years
- Analysis skills
- Health insurance
Sr. Regulatory Affairs Specialist
Prismatik Dentalcraft —Irvine, CA
- $86,000 - $120,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Research
- Health insurance
- Dental insurance
Quick Apply
Senior Salesforce Developer – Enterprise Applications
Qcells —Irvine, CA
- Full-time
- Computer science
- Computer Science
- Office
Quick Apply
Marketing Web Developer
YPM, Inc. —Irvine, CA
- $100,000 - $110,000 a year
- Full-time
- Mid-level
- 3 years
- Linux
7d
Senior Digital Marketing Manager
Tebra —Corona del Mar, CA
- $127,000 - $145,000 a year
- Email
- Remote
- 6 years
- Senior level
- Health insurance
- Work from home
Quick Apply
14h
Quality Assurance Manager
HR MGMT 10 LLC —Tustin, CA
- From $40 an hour
- Full-time
- Google Workspace
- Ability to walk for extended periods
- 5 years
Quick Apply
Strategic Pursuits Lead - Transportation
BKF —Newport Beach, CA
- $103,000 - $141,000 a year
- Full-time
- Hybrid work
- Marketing
- Office
- Bachelor's degree
- Profit sharing
- Paid holidays
Quick Apply
4d
Resident Support Specialist
Glen Park Senior Living —Long Beach, CA
- $25 - $27 an hour
- Full-time
- Spanish
- CPR Certification
- Google Workspace
Quick Apply
Associate Activation Specialist (Contractor) | Irvine, CA
Blizzard Entertainment —Irvine, CA
- $21.99 - $40.67 an hour
- Email
- Microsoft Excel
- Mid-level
- Analysis skills
- Health savings account
- AD&D insurance
Senior Quality Assurance Engineer
IMI Plc - Legacy Precision —Lake Forest, CA
- $80,000 - $150,000 a year
- Full-time
- Microsoft Excel
- Customer service
- ERP systems
- Health savings account
- Employee stock purchase plan
Paid Ads Specialist
HR MGMT 10 LLC —Costa Mesa, CA
- $60,000 - $80,000 a year
- Full-time
- Mid-level
- Organizational skills
- 2 years
Quick Apply
Senior Manager, Digital Marketing & Performance
Zymo Research Corporation —Tustin, CA
- $135,000 - $145,000 a year
- Email
- Office
- Analysis skills
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Senior Project Manager & Account Manager
Stantec —Irvine, CA
- $177,500 - $315,300 a year
- Full-time
- 11+ years
- Office
- Bachelor's degree
- Flexible schedule
Sr. Manager, Digital Marketing & Performance
Zymo Research —Tustin, CA
- $135,000 - $145,000 a year
- Email
- Office
- Analysis skills
- Continuous improvement
- Paid holidays
- Health insurance

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Sr Regulatory Affairs Specialist

Masimo -
Irvine, CA

Apply Now

Job Details

Full-time
$85,000 - $130,000 a year

Benefits

Paid parental leave
AD&D insurance
Paid holidays
Disability insurance
Health insurance
On-site gym
Dental insurance
401(k)
Flexible spending account
Parental leave
Employee assistance program
Vision insurance
Pet insurance

Qualifications

Computer operation
Microsoft Outlook
Computer literacy
Filing
GMP
Driver's License
Compliance documentation
Desktop applications
Biomedical regulatory compliance
ISO 13485
Database software proficiency

Full Job Description

Job Summary

Sr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual in this position will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances.

Duties & Responsibilities

Ownership of regulatory objectives in the management of international and domestic registrations of a product and/or country.
Drafting and compiling of 510(k) Premarket Notifications and other types of regulatory submissions.
Manage international and domestic filings/registrations.
Review and maintenance of Technical Documentation Summaries.
Document and review regulatory interpretations of regulations.
Active coordination with regional regulatory team members on product changes and regulatory notification/ approval requirements.
Take ownership of communications with regulatory team members to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.
Compile and submit product list on Certificate of Foreign Government and Free Sale Certificates.
Review and maintain product listings and establishment registrations with FDA.
Maintain regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements worldwide.
Interpret and train others to keep them up-to-date on international and domestic regulatory requirements.
Lead QA and Engineering in efforts to fulfill regulatory initiatives.
Represent RA department in project meetings and provide regulatory guidance.
Review and update RA quality system procedures as required (SQP/SOP’s).
Provide guidance to other departments on applicable regulations.
Review and approve document change orders.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications

Minimum of 3 years of work experience in a medical device Class II/ III environment.
- Expert level understanding of FDA or International Regulations.
- Experience with FDA/GMP requirements for medical device.
- Experience in Quality Systems per ISO 13485.
- Ability to work in a Project Team Environment.
- Must know regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.
- Computer Proficiency with MS Office (Word/Excel/Access/Outlook).
- Excellent verbal and written communication skills.
- Excellent prioritizing, organizational, and interpersonal skills.
- Excellent documentation skills including record maintenance/ tracking and understanding of document traceability.
- A detail-oriented individual, with a “can do” attitude, and the ability to work in a team environment, as well as individually (with minimal supervision).
- Ability to work in a fast-paced environment, with multiple tasks/projects.
Experience in patient monitor systems, hospital-based products, software or electronic device products.
- Experience with FDA/GMP requirements for medical device.
- Experience in Quality Systems per ISO 13485.

Preferred Qualifications

Experience leading and applying regulatory interpretations in the development of products.
Successful CE Mark of a Class II device.
Experience authoring and obtaining a 510(k) clearance.
Success in international and domestic product registrations.

Education

Bachelor’s degree is required, preferably in Engineering, Life Sciences, or Regulatory. Graduate degree preferred.

Compensation

The anticipated salary range for this position is $85,000 - $130,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance. Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center, Café. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Apply Now

Refine Your Search

senior qa specialist jobs in irvine, ca

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