20 Best jobs in Santa Ana, CA (Hiring Now!)

Specialist, Regulatory Affairs
Edwards Lifesciences —Irvine, CA
You may interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE…
$70,000 - $100,000 a year
Associate Veterinarian
Affordable Animal Hospital Group CA —Orange, CA
From spays and neuters to dental procedures, orthopedic procedures to non-routine surgeries, our board-certified veterinary specialists are well-versed in…
$120,000 - $200,000 a year
Quick Apply
Front of House Team Member
Chick-fil-A —Irvine, CA
Who make all their own employment decisions and are responsible for their own. Team Members are responsible for providing an exceptional dining experience for…
From $20 an hour
Quick Apply
13h
Behavioral Specialist
Innovate ABA —Irvine, CA
As a Behavior Specialist, you will work under the guidance of BCBAs to implement teaching methods and curriculum for the children on your caseload.
$18 - $22 an hour
Quick Apply
Associate Veterinarian
Villa Park Animal Clinic —Villa Park, CA
Progressive, client and patient oriented 2 doctor, privately owned practice is looking for an enthusiastic, energetic, professional and personable associate for…
$125,000 - $225,000 a year
Quick Apply
Religious School Teacher
University Synagogue —Irvine, CA
Encouraging students to ask questions and explore their own Jewish identity. I am currently looking for teachers for our 6th grade Torah portion class, 7th…
$30 - $55 an hour
Quick Apply
Charging Support
Rove Operating, LLC —Santa Ana, CA
Your interest in electric vehicle (EV) charging will be satiated through training so you will be able to effectively answer customer inquiries about EV and…
$19 - $20 an hour
Quick Apply
3h
Convenience Store Clerk
Gelson's Markets —Santa Ana, CA
Follow safety policies, store rules, and company regulations, including local, state, and federal regulations. We offer competitive union wages.
$21.50 - $26.85 an hour
Quick Apply
7d
Veterinary Technician
Veterinary Neurology Center —Tustin, CA
Veterinary technician: 2 years (Required). We provide health insurance to full time employees and offer participation in an employer matched retirement plan, as…
$28 - $36 an hour
Quick Apply
Appeals Specialist
Vertex Healthcare Services Inc. —Costa Mesa, CA
Responding to and completing appeals for low payments, denials, medical necessity denials. Identifying trends and/or root cause of issues, propose potential…
$17 - $20 an hour
Quick Apply
Patient Scheduler
Providence —Orange, CA
Responsible for the collection of patient demographics, billing and clinical information needed for entry into computer system.
$23.00 - $30.29 an hour
13h
Associate Veterinarian
PetWell Clinic South Orange County, CA —Lake Forest, CA
PetWellClinic® is one of the first walk-in veterinary clinics dedicated to assisting dog and cat owners in protecting their pets from diseases and parasites…
$145,000 - $180,000 a year
Quick Apply
Grant Writer
Hurtt Family Health Clinic —Tustin, CA
Bachelor’s degree in communications, business administration, grant administration, or similar field required. Social service programs: 2 years (Preferred).
$75,000 - $85,000 a year
Quick Apply
8d
Registered Nurse (RN)
VITAS Healthcare —Irvine, CA
Registered Nurse, RN, follows VITAS policies and standards (See VITAS Standards Manual) and practices within the scope of the RN license and has knowledge of…
$50 - $55 an hour
Sales Associate
Purple Haze Smoke Shop —Huntington Beach, CA
The Sales Associate’s responsibilities include working side by side with customers to determine their needs, answer their questions about our variety of…
From $20 an hour
Quick Apply
BUYER
CLASSIC PERFORMANCE PRODUCTS, INC —Placentia, CA
Able to extract technical requirements from CAD drawings. Can support the complexity of manufacturing, engineering, wholesale, retail and e-commerce sales…
From $25 an hour
Quick Apply
Sonography Performance Instructor
Link Mobile Medical Solution, Inc. —Irvine, CA
Valid driver’s license and willingness to provide at-home services as required. Regularly evaluate the performance of sonography staff, offering feedback and…
$100,000 - $145,600 a year
Quick Apply
Partner & Lead Veterinarian
Southern Veterinary Partners —Huntington Beach, CA
Licensure in good standing to practice in the state in which the applicant is applying. Ensure doctors effectively communicate physical examination findings,…
$168,000 - $750,000 a year
Quick Apply
Receptionist
Jet Mortgage a DBA of Home Mortgage Alliance Company (HMAC) —Santa Ana, CA
Transfer incoming calls to appropriate departments and maintain call logs. Answer phones and greet visitors and staff in person. Open and close the office.
$17 - $21 an hour
Quick Apply
1d
Receptionist
Related —Anaheim, CA
Providing timely and professional responses to phone calls and emails. Related will consider for employment qualified applicants with criminal histories in a…
$20 - $25 an hour
13h

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Specialist, Regulatory Affairs

Edwards Lifesciences - Irvine, CA

Apply Now

Job Details

Full-time $70,000 - $100,000 a year

Qualifications

Writing skills
3 years
Master's degree
Bachelor's degree
Product development

Full Job Description

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy.

Preparing documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions

Representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.

Strategizing and presenting alternatives for meeting regulatory requirements within regulatory affairs and cross-functionally

Resolving conflicts between those requirements and development issues

Advancing complex situations to management for guidance and training opportunities

You will prepare and oversee documentation packages for submission to global regulatory agencies

Tracking timelines and documents milestone achievements for inclusion in regulatory submissions.

You may interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)

Providing guidance on regulatory requirements necessary for contingency planning

Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s); proposing suggestions on utilizing regulatory updates to expedite approval process

Reviewing labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy

What you’ll need (Required):
Master’s degree and previous related experience OR Bachelor’s degree and 3 years of previous related experience

Coursework, seminars and/or other formal government and/or trade association training

What else we look for (Preferred):
Master’s degree in scientific discipline and 1 year of preparing (writing) domestic and international submissions

Bachelor’s degree in scientific discipline and 3 years preparing (writing) domestic and international submissions

Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III

Solid knowledge of global regulatory requirements for new products or product changes

Solid knowledge of new product development systems

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $70,000 to $100,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Apply Now

jobs in Santa Ana, CA

Specialist, Regulatory Affairs

Associate Veterinarian

Front of House Team Member

Behavioral Specialist

Associate Veterinarian

Religious School Teacher

Charging Support

Convenience Store Clerk

Veterinary Technician

Appeals Specialist

Patient Scheduler

Associate Veterinarian

Grant Writer

Registered Nurse (RN)

Sales Associate

BUYER

Sonography Performance Instructor

Partner & Lead Veterinarian

Receptionist

Receptionist

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