Irvine, California, United States · On-site
$95k–$95k/yr
Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $95,000.00 - $95,000.00 SalaryJob Category: QA - Quality ControlJob Title: Senior Specialist, Regulatory Affair…
Skills: Regulatory Affairs, Medical Device Regulations, Technical Writing, Project Management, Post-Market Surveillance
Irvine, California, United States · Hybrid
$72k–$96k/yr
Company Description WD is building the infrastructure behind the AI-driven data economy. As AI scales, so does data. Every interaction, every model, every system generates data that must be stored, managed, and made acce…
Skills: Calendar Management, Meeting Planning, Event Coordination, International Travel Management, Expense Reporting
Irvine, California, United States · On-site
$80k–$100k/yr
Job Summary The Clinical Complaint Specialist is responsible for the clinical assessment, evaluation, and processing of medical device complaints in support of regulatory compliance and product safety activities. This ro…
Skills: Clinical Assessment, Complaint Handling, Regulatory Compliance, Medical Device Reporting, Post-Market Surveillance
M&T BankIrvine, California, United States · On-site
$34/hr–$57/hr
Overview: Reporting to the SVP, Operations this position is responsible for collecting all levels and stages of delinquency in the M&T Equipment Finance Corporation (“MTEFC”) loan portfolio. Gathers and analyzes financia…
Skills: Debt Collection, Credit Analysis, Loss Mitigation, Collateral Valuation, Loan Modification
Irvine, California, United States · Hybrid
PSI is seeking a dedicated and compassionate Personal Injury Attorney to join our legal team in Irvine. The ideal candidate will have a strong background in personal injury law, with experience representing clients in ca…
Skills: Personal Injury Law, Litigation, Case Management, Legal Drafting, Negotiation
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Law Enforcement, Criminal Investigation, Traffic Enforcement, Community Engagement, Emergency Management
Irvine, California, United States · On-site
$142k–$269k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: 340B Program Strategy, Cross-functional Leadership, Regulatory Compliance, Pharmaceutical Operations, Strategic Planning
Irvine, California, United States · On-site
$49/hr–$54/hr
Overview AmTrust is actively seeking a skilled Resolution Examiner specializing in Workers' Compensation Claims. The primary focus will be on negotiating and settling claims efficiently and at a cost effective value. In …
Skills: Workers' Compensation Claims, Negotiation, Settlement Strategies, Claims Investigation, Reserve Adjustment
Irvine, California, United States · Hybrid
$150k–$170k/yr
We don't just practice employment law.We change it. California's premier plaintiff-side firm is looking for driven attorneys who want real courtroom time, real mentorship, and a real shot at becoming among the best litig…
Skills: Litigation, Employment Law, Courtroom Advocacy, Taking Depositions, Drafting Pleadings
Irvine, California, United States · On-site
$125k–$145k/yr
Overview Company Overview: Allied Universal®, North America’s leading security and facility services company, offers rewarding careers that provide you a sense of purpose. While working in a dynamic, welcoming, and colla…
Skills: Benefits Strategy, Leave of Absence Administration, Compliance Management, Vendor Management, Financial Analysis
Irvine, California, United States · On-site
$110k–$209k/yr
Company Description About AbbVie At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables,…
Skills: Project Management, Team Leadership, Promotional Review Process, FDA Regulations, Veeva
Kimball, Tirey & St. John LLPIrvine, California, United States · Hybrid
$175k–$250k/yr
Job DetailsJob Location: Irvine - Irvine, CA 92614Position Type: Full TimeEducation Level: Graduate DegreeSalary Range: $175,000.00 - $250,000.00 Base+Commission/yearJob Category: LegalWe are an established real estate a…
Skills: Civil Litigation, Employment Law, Legal Research, Legal Writing, Client Counseling
Irvine, California, United States · Hybrid
$72k–$96k/yr
Company Description WD is building the infrastructure behind the AI-driven data economy. As AI scales, so does data. Every interaction, every model, every system generates data that must be stored, managed, and made acce…
Skills: Calendar Management, Meeting Planning, Event Coordination, International Travel Management, Expense Reporting
Irvine, California, United States · Hybrid
Company Description WD is building the infrastructure behind the AI-driven data economy. As AI scales, so does data. Every interaction, every model, every system generates data that must be stored, managed, and made acce…
Skills: Calendar Management, Meeting Planning, Event Coordination, International Travel Management, Expense Reporting
Irvine, California, United States · Hybrid
Who We Are Through our service brands Hyundai Motor Finance, Genesis Finance, and Kia Finance, Hyundai Capital America offers a wide range of financial products tailored to meet the needs of Hyundai, Genesis, and Kia cus…
Skills: Commercial Credit Analysis, Financial Review, Cash Flow Analysis, Liquidity Assessment, Working Capital Management
Irvine, California, United States · On-site
$190k–$235k/yr
Job DetailsJob Location: Irvine Office - Irvine, CA 92612Education Level: JDSalary Range: $160,000.00 - $230,000.00 Salary/yearWe are looking for a junior to mid-level associate (approx. 2-5 years) to join our Labor and …
Skills: Employment Litigation, PAGA, Wage and Hour Class Actions, Advice and Counsel, OSHA Compliance
Irvine, California, United States · Hybrid
Who We Are Through our service brands Hyundai Motor Finance, Genesis Finance, and Kia Finance, Hyundai Capital America offers a wide range of financial products tailored to meet the needs of Hyundai, Genesis, and Kia cus…
Skills: Commercial Credit Analysis, Financial Review, Cash Flow Analysis, Liquidity Assessment, Working Capital Management
Irvine, California, United States · On-site
$190k–$235k/yr
Job DetailsJob Location: Irvine Office - Irvine, CA 92612Education Level: JDSalary Range: $160,000.00 - $230,000.00 Salary/yearWe are looking for a junior to mid-level associate (approx. 2-5 years) to join our Labor and …
Skills: Employment Litigation, PAGA, Wage and Hour Class Actions, Advice and Counsel, OSHA
Irvine, California, United States · On-site
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: ADA Compliance, FEHA Knowledge, Reasonable Accommodation Process, Interactive Dialogue Facilitation, Medical Documentation Interpretation
Irvine, California, United States · On-site
$140k–$170k
About CPT Group CPT Group has been a trusted leader in class action and bankruptcy administration since 1984. We support attorneys, corporations, courts, and consumers nationwide through claims administration, legal noti…
Skills: Microsoft Azure, Software Engineering, Terraform, Bicep, Infrastructure as Code
Irvine, California, United States • On-site
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Responsible for global regulatory affairs communication, negotiation, and the preparation of pre-market and post-market submissions. The role involves managing serious adverse event reporting and ensuring product labeling complies with global regulations.
Requires a Bachelor's degree in a scientific discipline and 3 to 5 years of experience in medical device Regulatory Affairs. Experience with US Class III cardiovascular devices is preferred.
Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $95,000.00 - $95,000.00 SalaryJob Category: QA - Quality ControlJob Title: Senior Specialist, Regulatory Affairs
Supervisor/Manager Title: Senior Manager, Regulatory Affairs
Job Location & Environment: Irvine, CA – Corporate Office Environment
Job Description Summary: Responsible for global regulatory affairs communication, regulatory negotiation and correspondence tracking, serious adverse event reporting, post-market surveillance, competitive intelligence, and maintenance of standards program. Under supervision, prepares clinical, pre-market and post-market submissions and query response development and communicates with regulatory authorities and partners. Provides expertise in translating regulatory requirements into practical, workable plans. Provides counsel to project teams as applicable. Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies).
Under supervision, lead the preparation, submission, and maintenance of high-quality global filings for investigational device authorizations and registrations, annual reports, and amendments/supplements, communicating with regulatory authorities as applicable.
Serve as the regulatory team member of product development and sustaining teams, providing clear direction and input to assure that applicable global requirements are incorporated in the development process and to drive attainment of company objectives.
Interpret existing or new regulatory requirements as they relate to company products and procedures, labeling, marketing projects, clinical studies, testing, or record keeping.
Manage and oversee submission of serious adverse event reporting, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with competent authorities and other external stakeholders.
Review and approve FMEAs/risk analyses, protocols, reports, other technical documents.
Review product labeling for compliance with global labeling regulations.
Maintain regulatory intelligence through continuous monitoring of regulatory landscape.
Review and approve document change orders and prepare letters-to-file.
Update departmental procedures as required.
Produce monthly reports on global activities, issues, recommendations, and plans going forward.
Participate in external audits as needed.
Perform other duties as assigned by supervisor.
Experience in applying global medical device regulations and product development process
Comprehensive knowledge of quality systems and relationship to business
Ability to interpret regulatory standards and guidance and provide direction to project teams
Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
Self-motivated and self-disciplined; able to prioritize multiple tasks and responsibilities.
Effective interpersonal skills/diplomacy and problem-solving techniques.
Excellent applied thinking and technical writing skills.
Strong communication and organization skills required.
Bachelor’s degree in a scientific discipline or equivalent is required.
Minimum of 3 to 5 years in medical device Regulatory Affairs or other relevant experience.
Experience with US Class III cardiovascular devices preferred.
Strong verbal and written communication, organization, and project management skills required.
Diplomacy and cultural sensitivity are essential attributes.
Works on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality.
Exercises good judgment within generally defined practices and policies in all aspects of the job.
Normally receives no instruction on routine work, and general instructions on new assignments.
Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.
Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.
Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.
Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.
Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.
Written Communication: Write clearly and informatively; Create documents that are complete and accurate.
Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.
Decisions: Make timely and sound decisions; Take risks and manage them intelligently.
Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.
Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles, and ages; Foster open communication and respect for the individual.
Equipment Use: Copy machines, personal computers, and computer terminals.
Computer Skills: Software proficiency in Microsoft Office Suite.
Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.
Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Up to 20% travel required and ability to travel OUS.
Ability to occasionally lift and/or move up to 20 pounds.
Aortic regurgitation is different. So is our valve.
JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis. In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR. JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.
Offices: 4 Cromwell, Suite 100, Irvine, CA 92618, US
There are currently 192 open legal positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Allergan, Hyundai Capital America, Kahana Feld, MG+M The Law Firm, UCI Health, among others. Browse the listings above to see every active employer.
Yes — 94 of the 192 open legal positions offer remote or hybrid work (24 remote, 70 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
