Top 1538 Medical device company Jobs in Irvine, Ca

Compliance Specialist
Össur —Irvine, CA
- $61,123 - $95,394 a year
- Full-time
- Mid-level
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
NPI Buyer
Kardion —Irvine, CA
- $105,000 - $125,000 a year
- Full-time
- Oracle
- 5 years
- English
- Health insurance
- Dental insurance
Quick Apply
Scientist I
Advanced Sterilization Products —Irvine, CA
- $58,995 - $98,555 a year
- Bachelor's degree
- Communication skills
- Entry level
Associate Medical Sales Representative
Paragon 28, Inc. —Orange County, CA
- Weekends as needed
- Inventory control
- Mid-level
- Driver's License
Medical Supply Sales Rep
Crown Medical, Inc. —Newport Beach, CA
- $85,411 - $116,662 a year
- Full-time
- Driver's License
- Organizational skills
- Communication skills
Quick Apply
Orthopedic Medical Rep
Crown Medical, Inc. —Irvine, CA
- $82,668 - $113,919 a year
- Full-time
- Driver's License
- Organizational skills
- Communication skills
Quick Apply
WIM Investigator II, AmSec WIM
Amazon.com Services LLC —Irvine, CA
- $74,400 - $130,100 a year
- Full-time
- Mid-level
- Psychology
- Mentoring
- AD&D insurance
- Health insurance
Clinical Research Associate
Diality —Irvine, CA
- $120,000 - $135,000 a year
- Full-time
- Nursing
- Up to 50% travel
- Writing skills
Quick Apply
Complaint Quality Engineer II - PMS
Edwards Lifesciences —Irvine, CA
- $87,000 - $123,000 a year
- Full-time
- Engineering
- Laboratory experience
- No experience needed
Operations Manager
Anderson Sport and Wellness —Newport Beach, CA
- $45 - $55 an hour
- Contract
- Physical & Rehabilitation Medicine
- Clinic experience
- Mid-level
- Health insurance
- Paid time off
Quick Apply
Document Control Specialist
Prismatik —Irvine, CA
- $23 - $25 an hour
- Full-time
- Microsoft Outlook
- Mid-level
- Office
QA Commercial Manager
FUJIFILM —Santa Ana, CA
- $106,185.25 - $138,230.00 a year
- Microsoft Word
- 5 years
- Bachelor of Science
- Health insurance
- Dental insurance
Administrative Assistant, Capital Markets
US AMR-Jones Lang LaSalle Americas, Inc. —Irvine, CA
- $70,000 - $80,000 a year
- Overtime
- Background check
- Microsoft Outlook
- Word processing
- Paid parental leave
- Paid holidays
Quick Apply
Co-Op, Finance
Precision Castparts Corp. —Irvine, CA
- $21 - $23 an hour
- Monday to Friday
- Office
- Finance
- Continuous improvement
- Paid holidays
- Health insurance
Senior Labeling Specialist
Edwards Lifesciences —Irvine, CA
- $92,000 - $130,000 a year
- Full-time
- 5 years
- English
- Bachelor's degree
Patient Enrollment Specialist
Vitasigns LLC —Newport Beach, CA
- $25 - $35 an hour
- Email
- Spanish
- Software troubleshooting
- Medical office experience
Quick Apply
3d
Technical Writer
Edwards Lifesciences —Irvine, CA
- $68,000 - $96,000 a year
- Full-time
- Microsoft Excel
- English
- Mid-level
Senior Product Manager, Professional Education
Edwards Lifesciences —Irvine, CA
- $121,000 - $171,000 a year
- Full-time
- 6 years
- Sales
- Master's degree
10d
Medical Equipment Sales Rep
Crown Medical, Inc. —Laguna Niguel, CA
- $83,106 - $114,357 a year
- Full-time
- Driver's License
- Organizational skills
- Communication skills
Quick Apply
Assembler I
Beta Bionics, Inc. —Irvine, CA
- $19 an hour
- Evening shift
- English
- Warehouse
- Manufacturing

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Compliance Specialist

Össur -
Irvine, CA

Apply Now

Job Details

Full-time
$61,123 - $95,394 a year

Benefits

Health insurance
Dental insurance
Vision insurance
401(k) matching

Qualifications

Quality control corrective actions
Confidential information handling
Program management
Quality records maintenance
Process audits
Medical law
Program development
Compliance audits & assessments
Data reporting
Corrective and preventive actions (CAPA)
Implementing healthcare compliance training programs
Mid-level
State healthcare regulations
Audit Reporting
Collaboration with product development teams
Policy & process development
Bachelor's degree
Quality risk management
Corporate training program coordination
Quality control documentation
Continuous improvement
Pharmaceutical company experience
Quality compliance management
Data interpretation
Internal control implementation
Developing new training programs
Biomedical regulatory compliance
Healthcare regulatory compliance policy development
Healthcare policy implementation
Reporting on compliance risks

Full Job Description

About Us

Össur is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Significant ongoing investment in research and development has led to over 2,100 patents, award-winning designs, and successful clinical outcomes.

Össur is focused on improving people’s mobility through the delivery of Prosthetics and Bracing & Supports solutions. Helping people live a Life Without Limitations is why we exist as a company.

About the Role

The Compliance Specialist is responsible for assisting the Director of Compliance in the management of the compliance program for Embla Medical’s Americas Business Units. This role is responsible for management of compliance functions that ensure that the organization follows state and federal regulations including state insurance laws, federal laws and regulations, and company’s code of conduct.

What You’ll Do

Support the administration and continuous improvement of the Americas compliance program, including compliance systems, processes, documentation, and reporting
Assist with auditing and monitoring activities across applicable Americas business units, including tracking findings, documenting results, and supporting corrective action plans
Manage compliance systems and platforms, including transparency reporting
Help coordinate compliance training and education, including training assignments, completion monitoring, reminders, records, and escalation of overdue assignments
Ensure that compliance controls operate effectively across the relevant business units and collaborate with business leaders as appropriate
Promote a culture that encourages ethical conduct and a commitment to compliance
Develop policies and programs that encourage managers and employees to report compliance issues
Recommend and/or implement control enhancements when control deficiencies are identified.
Ensure company-wide communication of compliance policies and procedures.
Collaborate in the development, implementation and monitoring of compliance education and training
Act as a key contact to key stakeholders’ associates for all compliance-related questions or concerns
Explain such regulations, policies and procedures to company personnel and assist the product implementation teams in the development of related business requirements
All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific.
All training related to the quality management system is done in accordance to the Training Management Process (QM1681).
Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company’s representative at all times.
Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.

Who You Are

Basic knowledge in risk identification, risk assessment, controls development, training, monitoring, and reporting.
Basic understanding of the laws and regulations that impact medical device companies such as anti-kickback, sunshine act, false claims act, stark law, consumer protection laws, FDA, FCPA and AdvaMed.
Basic understanding of DOJ enforcement actions, corporate compliance guidance and corporate integrity agreements.
Ability to use discretion and independent judgment to manage and impart confidential information.
Knowledge of local, state, and federal laws, regulations, and legislation, especially related to medical device sales.
Strong critical thinking skills and the ability to analyze, summarize, and effectively present data.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies.
Demonstrated understanding of compliance systems and controls.
Preferred Qualifications:
- Bachelor’s Degree in degree in related field
- 2-4 years of relevant working experience in healthcare compliance preferably in medical device or pharma industry setting

Why You’ll Feel Good Working Here

Join our team if you want to make a lasting impact; we will support you along the way.

We value a diverse working environment and a welcoming and fun company culture
We empower our colleagues and encourage close collaboration, allowing us to develop the best products and maintain the highest possible standards of care
Competitive Compensation and Benefit Packages
Medical, Dental, and Vision Benefits
401(k) Retirement Plan with employer matching contribution

The US base pay range for this full-time position is $61,123 - $95,394 + bonus + benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire pay rates. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Embla Medical is committed to sustainable business practices and renowned for positively impacting people‘s health and well-being

Embla Medical is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best available individual in every job.

Embla Medical's equal opportunity policy prohibits all discrimination (based on race, color, creed, sex, religion, marital status, age, national origin or ancestry, physical disability, mental disability, military service, pregnancy, child birth or related medical condition, actual or perceived sexual orientation, or any other consideration made unlawful by local laws around the world).

Embla Medical is committed to complying with all applicable laws providing equal employment opportunities. This commitment applies to all individuals involved in the operations of Embla Medical and prohibits discrimination by any employee of Embla Medical, including supervisors and co-workers.

Important Warning: Beware of fraudulent recruiters impersonating our company. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. We will never ask you for any form of payment during the recruitment process. Please make sure you refer to our official website .

Apply Now

Refine Your Search

medical device company jobs in irvine, ca

Compliance Specialist

NPI Buyer

Scientist I

Associate Medical Sales Representative

Medical Supply Sales Rep

Orthopedic Medical Rep

WIM Investigator II, AmSec WIM

Clinical Research Associate

Complaint Quality Engineer II - PMS

Operations Manager

Document Control Specialist

QA Commercial Manager

Administrative Assistant, Capital Markets

Co-Op, Finance

Senior Labeling Specialist

Patient Enrollment Specialist

Technical Writer

Senior Product Manager, Professional Education

Medical Equipment Sales Rep

Assembler I

I want to receive the latest job alert for medical device company in irvine, ca

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