Top 293 compliance Jobs in irvine, ca

Sr. Regulatory Affairs Specialist
Prismatik Dentalcraft —Irvine, CA
- $86,000 - $120,000 a year
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
Public Works Labor Compliance Specialist
Confidential —Orange, CA
- From $25 an hour
- Full-time
- Mid-level
- 3 years
- Analysis skills
- Paid time off
- Flexible schedule
Quick Apply
Compliance Coordinator - Healthcare (FQHC Community Clinic)
Hurtt Family Health Clinic —Tustin, CA
- $28 - $30 an hour
- Full-time
- Spanish
- HIPAA
- English
- 403(b) matching
- Health savings account
Quick Apply
Regulatory Reporting Manager
Deloitte —Costa Mesa, CA
- $82,600 - $162,800 a year
- Full-time
- 6 years
- Finance
- Bachelor's degree
12d
Compliance Specialist
Logan Property Management —Lakewood, CA
- $60,000 - $68,000 a year
- Extended hours
- Spanish
- 6 years
- English
Quick Apply
Compliance Analyst I
COMMERCEWEST BANK —Irvine, CA
- $70,000 - $80,000 a year
- Full-time
- Research
- Office
- Analysis skills
Quick Apply
Compliance Analyst
CommerceWest Bank —Irvine, CA
- $50,000 - $65,000 a year
- Full-time
- Research
- Mid-level
- Office
Quick Apply
Licensed Customs Broker / Compliance Officer
EAST-WEST ASSOCIATES INC. —Orange, CA
- $95,000 - $105,000 a year
- Full-time
- Mid-level
- Office
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Compliance Manager
Wismettac Asian Foods Inc —Santa Fe Springs, CA
- $88,764 - $110,955 a year
- Full-time
- Background check
- Microsoft Excel
- 6 years
- Health savings account
- Health insurance
Quick Apply
1d
In-House Counsel
MondayOne LLC —Newport Beach, CA
- Up to $200,000 a year
- 8 hour shift
- 5 years
- Employment & labor law
- In-person
- Health insurance
- Paid time off
Quick Apply
Senior In-House Counsel-Real Estate & Employment Law California
Confidential —Cerritos, CA
- $150,000 - $200,000 a year
- Full-time
- 5 years
- Residential
- In-person
- Health insurance
- Dental insurance
Quick Apply
5d
Human Resources Manager (Tax/Compliance) #11309
Leverages U.S. Inc. (Shigotosagashi.com) —Cerritos, CA
- $87,000 - $91,000 a year
- Full-time
- Background check
- Spanish
- English
- Health insurance
- Dental insurance
Quick Apply
7d
Compliance Associate
Friendship Shelter —Laguna Woods, CA
- $26.23 an hour
- Full-time
- Mid-level
- Office
- Administrative experience
- Health savings account
- Health insurance
Quick Apply
Labor Compliance Specialist/Accountant
Alliance Resource Group —Long Beach, CA
- $70,000 - $75,000 a year
- Full-time
- Mid-level
- Windows
- Microsoft Office
- Health insurance
- Dental insurance
Quick Apply
13d
Food Regulatory Compliance Specialist
Accelera —Cypress, CA
- $27.41 - $35.75 an hour
- Full-time
- Microsoft Excel
- Mid-level
- Analysis skills
Quick Apply
Compliance / Paralegal Coordinator
Eterna Management —Santa Ana, CA
- $29 - $32 an hour
- Full-time
- Spanish
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
Product Compliance Specialist
Jet Mortgage a DBA of Home Mortgage Alliance Corporation —Santa Ana, CA
- $60,000 - $65,000 a year
- Full-time
- Hybrid work
- Background check
- Customer service
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
5d
Compliance Auditor
Avanath —Irvine, CA
- $28.85 - $31.35 an hour
- Microsoft Excel
- Microsoft Outlook
- Writing skills
- Paid holidays
- Health insurance
Quick Apply
1d
Pharmacy Part D Auditor
Clever Care Health Plan —Huntington Beach, CA
- $80,000 - $90,000 a year
- Full-time
- Hybrid work
- Background check
- Bachelor of Science
- Mid-level
- Health insurance
Care Management and Population Health Auditor
Clever Care Health Plan —Huntington Beach, CA
- $80,000 - $90,000 a year
- Full-time
- Hybrid work
- Background check
- Mid-level
- Office
- Health insurance

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Sr. Regulatory Affairs Specialist

Prismatik Dentalcraft
Irvine, CA

Quick Apply

Job Details

Full-time
$86,000 - $120,000 a year

Benefits

Health insurance
On-site gym
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
401(k) matching
Life insurance

Qualifications

FDA submissions
Teamwork
Microsoft Excel
Writing skills
Bachelor's degree
Technical writing
Regulatory submissions
Time management

Full Job Description

Prismatik Dentalcraft is a division of Glidewell Dental.

Essential Functions:

Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
Maintains company registrations and device listings in the US, Canada, and the EU.
Analyzes and reports department metrics.
Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
Informs coordinator of product recalls.
Performs and supports internal, external, and third-party audits.
Maintains knowledge on current regulations and guidelines.
Evaluates compliance with applicable regulations, project policies, and procedures
Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
Composes audit plans and reports.
Conducts audits and inspections of GMP and non-regulated documentation.
Tracks internal and external corrective and preventive actions.
Performs other related duties and projects as business needs require at direction of management.

Knowledge and Abilities:

Proficient knowledge of general office procedures.
Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
Proficient quantitative and analytical skills.
Demonstrated prioritization and time management skills.
Demonstrated negotiation abilities.
Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
Demonstrated high standard of quality of work.
Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
Demonstrated reliability, dependability, and flexibility in work habits.
Demonstrated attention to detail and accuracy.
Ability to analyze and collate data for presentations and reports.
Ability to prioritize and organize project tasks and goals effectively.
Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
Ability to interpret and collate data to present an accurate picture of market potential.
Ability to research new and emerging technologies and practices.
Ability to read technical diagrams, graphs, and instructions.

Education and Experience:

Bachelor’s degree in related field preferred
Minimum five (5) years of experience in Regulatory Affairs.
Minimum two (2) years of experience in software-based medical devices (e.g., SaMD or SiMD).
Experience in preparing (writing) domestic and international product submissions, required.

Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!

In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!

Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.

Job Type: Full-time

Pay: $86,000.00 - $120,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
On-site gym
Paid time off
Vision insurance

Application Question(s):

How many years of work experience do you have with 510(k)?
Do you have experience in authoring a 510(k) from scratch?
Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa, STEM OPT, etc)?
Do you have experience with new product development? (NPD)
Do you have experience with both the design control and change control process?

Ability to Commute:

Irvine, CA 92612 (Required)

Work Location: In person

Quick Apply

Refine Your Search

compliance jobs in irvine, ca

Sr. Regulatory Affairs Specialist

Public Works Labor Compliance Specialist

Compliance Coordinator - Healthcare (FQHC Community Clinic)

Regulatory Reporting Manager

Compliance Specialist

Compliance Analyst I

Compliance Analyst

Licensed Customs Broker / Compliance Officer

Compliance Manager

In-House Counsel

Senior In-House Counsel-Real Estate & Employment Law California

Human Resources Manager (Tax/Compliance) #11309

Compliance Associate

Labor Compliance Specialist/Accountant

Food Regulatory Compliance Specialist

Compliance / Paralegal Coordinator

Product Compliance Specialist

Compliance Auditor

Pharmacy Part D Auditor

Care Management and Population Health Auditor

I want to receive the latest job alert for compliance in irvine, ca

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