Irvine, California, United States · On-site
$139k–$196k/yr
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As …
Skills: People Management, Clinical Safety Oversight, Talent Development, Risk Management, Clinical Trial Design
Irvine, California, United States · On-site
$85k–$115k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Equipment Calibration, OOT Investigation, Blue Mountain CMMS, Veeva, GMP Compliance
Irvine, California, United States · On-site
$80k–$140k/yr
From Engine Bay to Payload, we protect vital structures and systems. Hera Technologies is a premier contract manufacturer specializing in high-precision metallic and non-metallic solutions for the Aerospace, Defense, Spa…
Skills: Project Management, Production Planning, ERP Systems, Risk Mitigation, Cross-functional Leadership
Irvine, California, United States · On-site
$30/hr–$34/hr
RESPONSIBILITIES: • Perform and/or assist with analytical testing of raw materials, in-process samples, and finished products. • Utilize analytical laboratory instrumentation with minimal supervision. • Co…
Skills: Analytical Testing, cGMP Regulations, Peer Review, Equipment Calibration, HPLC
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: Pre-operative Assessment, Anesthesia Administration, Patient Monitoring, Airway Management, Regional Anesthesia
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: Pre-operative Assessment, Anesthesia Administration, Patient Monitoring, Airway Management, Intubation
Irvine, California, United States · Hybrid
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: Research Compliance, Regulatory Oversight, Case Management, Public Speaking, Technical Writing
Irvine, California, United States · On-site
$128k–$128k/yr
Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $127,500.00 - $127,500.00 Salary/yearJob Category: EducationJob Title: Specialist, Field Clinical Supervisor/Ma…
Skills: Clinical Case Support, Product Advocacy, Technical Training, Vascular Procedural Knowledge, Relationship Management
Irvine, California, United States · On-site
$134k–$134k/yr
Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $134,100.00 - $134,100.00 SalaryJob Title: Staff Engineer, THV Research and Development Staff Engineer I, Resea…
Skills: Solidworks, CAD, Project Management, Statistical Analysis, Design Verification
Irvine, California, United States · On-site
$125k–$223k/yr
Location: Irvine, United States of America Thales people architect solutions that enable two-thirds of planes to take off and land safely. We create in-flight entertainment systems that engross 50 million fliers every ye…
Skills: Mechanical Design, Thermal Management, Structural Integrity, Vibration Analysis, EMI/ESD
Irvine, California, United States · On-site
$126k–$178k/yr
Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technolog…
Skills: Upstream Marketing, Product Strategy, Voice-of-Customer Insights, Project Management, KOL Relationship Management
Irvine, California, United States · On-site
$144k–$194k/yr
The Amazon Devices Software & Services team is looking for a Software Development Engineer to join a high-velocity, specialized team. This is not a traditional framework or infrastructure role - we are building a new gro…
Skills: Software Development, Systems Architecture, AI Infrastructure, LLM Integration, Backend Services
Irvine, California, United States · On-site
$365k–$400k/yr
Job Summary: Masimo is seeking a results-driven and collaborative SVP, Marketing to lead our global marketing efforts and drive continued growth in the medical device and healthcare technology industry. Reporting to the …
Skills: Marketing Strategy, Brand Development, Product Commercialization, B2B Healthcare Marketing, Market Intelligence
Irvine, California, United States · On-site
Who We Are UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system based in Orange County. UCI Health is comprised of its main campus, UCI Medical Center, a 459-…
Skills: Binocularity Analysis, Ocular Motility Treatment, Patient Triage, Clinical Supervision, Training Program Development
Irvine, California, United States · On-site
$110k–$209k/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: Systems Design, Clinical Technology, CDASH, SDTM, Project Management
Irvine, California, United States · On-site
$125k–$237k/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: Clinical Database Design, Data Loading, Database Modeling, SAS Programming, SQL Programming
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: Financial Analysis, Grant Management, Contract Management, Fiscal Management, Compliance Regulations
Irvine, California, United States · Remote OK
Overview When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global …
Skills: KOL Relationship Management, Scientific Communication, Clinical Trial Methodology, Vascular Biology, Data Analysis
Irvine, California, United States · On-site
$75k–$96k/yr
Job DetailsJob Location: SDC US - Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $74,836.00 - $96,057.00 SalaryPosition Summary: This position is expected to be in-person, and the ind…
Skills: ISO 9001, ISO 14001, Quality Assurance, Root Cause Analysis, Internal Auditing
Irvine, California, United States · On-site
As Laboratory Technician at IDEXX, you perform laboratory testing that helps veterinarians diagnose and treat pets. You will be a key contributor at one of the largest veterinary diagnostic companies in the world, joinin…
Skills: Laboratory Testing, Automated Analyzers, Microscopy, Pipetting, Clinical Diagnostic Analyzers
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Manage and oversee a team of clinical research professionals to drive safety-related activities within the Transcatheter Heart Valve business unit. Develop safety strategies, align processes, and act as a liaison between cross-functional stakeholders and regulatory authorities.
Requires a Bachelor's degree in a related field with 5-7 years of relevant experience and a demonstrated track record in people management. Preferred qualifications include a Master's degree and experience in the medical device or pharmaceutical industry.
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Senior Manager, Clinical Safety will manage a team of clinical research professionals providing oversight, mentoring and guidance to drive results in support of safety related activities within the Transcatheter Heart Valve business unit.
This role requires onsite presence at our corporate headquarters in Irvine, CA.
Manage and oversee the work of the clinical safety team, providing oversight and guidance cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
Develop and ensure alignment of safety processes (e.g., safety work instructions and documents, SOPs, charters) as needed. Identify risk, develop and lead in the implementation of clinical safety strategies which may include negotiations with internal and external parties
Act as a liaison to key cross-functional stakeholders (e.g., PMO, Clinical Affairs, Regulatory Affairs, Quality, study sites leadership) regarding Safety-related matters
Provide input on clinical trial design and safety sections of study protocols, CRFs, regulatory submissions, and clinical/regulatory reports and provide input to regulatory affairs questions on safety related issues
Represent safety in internal and external audits
Bachelor's Degree in in related field, with 5-7 years previous related experience or equivalent work experience based on Edwards criteria
Demonstrated track record in people management or equivalent work experience based on Edwards criteria
Master's Degree or equivalent in related field
Experience in Medical device or pharmaceutical industry, Clinical research, or in-hospital clinical and/or managerial experience or equivalent work experience based on Edwards criteria
Experience working in a regulated industry or equivalent work experience based on Edwards criteria
Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Good understanding of related aspects of clinical studies processes and/or systems
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value to the business
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 (CA), the base pay range for this position is $139,000 to $196,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
There are currently 497 open science & research positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Edwards Lifesciences, Allergan, UCI Health, Tarsus Pharmaceuticals, Inc., FieldAI, among others. Browse the listings above to see every active employer.
Yes — 103 of the 497 open science & research positions offer remote or hybrid work (29 remote, 74 hybrid).
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