Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnost…
Skills: Regulatory Strategy, FDA Submissions, International Product Registration, Premarket Notifications, PMA Supplements
The Aerospace Corporation is the trusted partner to the nation’s space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded research and development ce…
Skills: Systems Integration, Space Systems Engineering, Architecture Evaluation, Acquisition, Technical Leadership
The Opportunity The Camera Raw team at Adobe is seeking an experienced Software Engineer to own the technical transfer of AI/ML models from research and training into shipping imaging products. This role sits at the inte…
Skills: C++, Machine Learning, Model Optimization, CoreML, ONNX
As a Global Product Planner for Cell Therapy at AstraZeneca, you will be instrumental in driving the strategic planning and execution of our innovative cell therapy products across the global supply chain. This role offe…
The Aerospace Corporation is the trusted partner to the nation’s space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded research and development ce…
Skills: Electro-Optical/Infrared Modeling, Synthetic Scene Generation, Radiometry, Radiative Transfer Modeling, Image Chain Analysis
The Aerospace Corporation is the trusted partner to the nation’s space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded research and development ce…
Skills: Physical layer modeling & simulation, Communication waveform design, Link budget analysis, Digital signal processing, RF satellite communication systems
Senior Director SoC Architecture - AI Accelerators (Multiple Locations)
San Diego, California, United States · On-site
$250k–$376k/yr
Senior+$4M raised
Company:Qualcomm Technologies, Inc. Job Area:Engineering Group, Engineering Group > ASICS Engineering General Summary: Qualcomm’s Data Center organization is redefining next-generation compute platforms by delivering hig…
Skills: SoC Architecture, ASIC Design, Rack-Scale Systems Architecture, AI Accelerators, Platform Integration
Robotics Systems Integration and Test Engineer - Qualcomm Advanced Robotics Team
San Diego, California, United States · On-site
$123k–$184k/yr
Mid level$4M raised
Company:Qualcomm Technologies, Inc. Job Area:Engineering Group, Engineering Group > Multimedia Systems General Summary: About Qualcomm Robotics Qualcomm Advanced Robotics Team is building the AI first stack and platform …
Skills: Robotics Systems Integration, AI Deployment, ROS/ROS2, Perception, Motion Planning
** Internal Workers – Please log into your Workday account to apply ** Huntington Hospital Employee Login Expectations: Performs a variety of standardized tests and procedures in conjunction with associated clerical and …
** Internal Workers – Please log into your Workday account to apply ** Huntington Hospital Employee Login Expectations: Performs a variety of standardized tests and procedures in conjunction with associated clerical and …
Associate Medical Director, Safety Evaluation and Risk Management (SERM)
London, England, United Kingdom · Hybrid
Senior
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicin…
Skills: Clinical Development, Communication, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP)
San Francisco, California, United States · On-site
Mid level
Job Summary: This position sits within the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG), and supports the LIINC (Long-term Impact of Infection with the Nove…
San Francisco, California, United States · On-site
Mid level
The Clinical Laboratory at Zuckerberg San Francisco General, Blood Bank/Transfusion Service performs pre-transfusion compatibility testing in preparation for selecting, cross matching and issuing blood and blood componen…
San Francisco, California, United States · On-site
$91k–$194k/yr
Senior
Job Function Summary: Involves conceiving, researching, writing, editing, and / or publishing written materials and strategic communications, including publications, articles, proposals, speeches, and promotional materia…
Job DetailsJob Location: Fremont HQ - Fremont, CA 94538Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $75,000.00 - $95,000.00 SalaryJob Category: EngineeringSummary: This role is tailored for inspect…
Skills: KLA ICOS, IC Packaging, Thermal Analysis, Python, C/C++
Job DetailsLevel: ExperiencedJob Location: Torrance, CA 90505Position Type: Full TimeSalary Range: $105,000.00 - $150,000.00 Salary/yearJob Shift: DayJOB SUMMARY: Robinson Helicopter Company is a leading manufacturer of …
Skills: Seat Design, Human Factors, CAD, Solidworks, CATIA
Job DetailsLevel: ExperiencedJob Location: Torrance, CA 90505Position Type: Full TimeSalary Range: $105,000.00 - $160,000.00 Salary/yearJob Shift: DayRobinson Helicopter Company is a leading manufacturer of civil rotorcr…
Skills: Material Selection, Material Testing, Manufacturing Process Development, Root Cause Analysis, Corrosion Resistance Analysis
Lambda, The Superintelligence Cloud, is a leader in AI cloud infrastructure serving tens of thousands of customers. Our customers range from AI researchers to enterprises and hyperscalers. Lambda's mission is to make com…
Director of Technology, New Ventures — Cedars-Sinai Digital Innovation Platform
Los Angeles, California, United States · Hybrid
Senior$175M raised
About the Company Redesign Health is a global venture and applied technology firm focused on building next-generation healthcare companies. We manage venture capital and venture buyout strategies, each powered by an AI o…
The Clinical Technician (TMS) plays a key role in delivering advanced interventional treatments for psychiatric and neurological conditions at Salma Health. This position primarily supports Transcranial Magnetic Stimulat…
Skills: Transcranial Magnetic Stimulation, Patient Monitoring, EHR Documentation, Patient Scheduling, Esketamine Administration
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$90k–$180k/yr
Full-time
bachelor degree
Medical coverage (HIP PPO medical plan), Retirement savings plan, Tuition reimbursement, Freedom 2 Save student debt program, FreeU education benefit
Posted 10d ago
~40 hrs/week
Responsibilities
Develop and execute worldwide regulatory strategies for the approval of new and modified heart failure medical devices. Coordinate the preparation and submission of regulatory documentation to the FDA and international agencies while ensuring post-marketing compliance.
Requirements
Requires a Bachelor's degree and 3-4 years of experience in a regulated industry, with a preference for experience in Class II/III medical devices. Candidates must possess strong communication skills and the ability to navigate complex regulatory requirements and submissions.
Full job description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Heart Failure Business
Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.
The Opportunity
We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in Pleasanton, CA. This team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
What You’ll Work On
Develops worldwide strategies for regulatory approval of new and modified products.
Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Guides teams to provide content for submissions and participates in design reviews as needed.
Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
Reviews, edits, and approves Advertising and Promotional materials.
Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies, ensuring that communications are relevant, specific and convey all necessary detail.
Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate personnel.
Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
Interfaces directly with regulatory agencies as needed.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
Communicates with and maintains productive, constructive relationships with external customers as required – regulatory authorities, Notified Bodies, in-country affiliates and/or distributors.
Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Required Qualifications
Bachelor's Degree in a related field OR an equivalent combination of education and work experience
3-4 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
Strong organizational and follow-up skills, as well as attention to detail.
Organize and track complex information.
Exercise good and ethical judgment within policy and regulations
Use in-depth knowledge of business functions and cross group dependencies/ relationships.
Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.
Preferred Qualifications
Minimum of 5 years’ experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus
Experience with either 510(k) applications, PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions.
Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
Experience with word processing, spreadsheet and presentation graphic software packages is required.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Ability to identify, solve problems, and work independently with little oversight.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes, and meets deadlines in a timely manner.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
HF Heart Failure
LOCATION:
United States > Pleasanton : 6101 Stoneridge Dr
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Regulatory AffairsMedical DevicesFDA510(k)PMAEuropean DossiersClass II Medical DevicesClass III Medical DevicesRAC CertificationQuality SystemsClinical InvestigationsQMSEMSNotified BodiesGTS DatabaseHeart Failure
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Terms of Use: https://www.abbott.com/social-media-terms-of-use.html
Privacy Policy: https://abbo.tt/privacy
Offices: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, US
How much do Science & Research jobs in California pay?
Based on 11509 listings with disclosed salaries, most science & research jobs in California pay between $101k–$250k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in California right now?
There are currently 18,233 open science & research positions in California listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in California?
Companies currently hiring include Applied Materials, Northrop Grumman, Google, Apple, Northrop Grumman Mission Systems, Inc., among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in California?
Yes — 3803 of the 18233 open science & research positions offer remote or hybrid work (976 remote, 2827 hybrid).
How do I apply for Science & Research jobs in California?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.