regulatory affairs Jobs in california

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Senior Regulatory Affairs Specialist

ZennSoft

Union City, California, USA

Full-time

Job Title: Senior Regulatory Affairs (RA) Specialist Location: Union City, CA Industry: Medical Devices / Regulatory Affairs Employment Type: Full-Time Client: Lhasa OMS, Inc. About the Role Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA. The ideal candidate will support the Regulatory Affairs department by preparing and submitting regulatory documentation for medical devices in both domestic and international markets. This p

Senior Regulatory Affairs Licensing Engineer (remote eligible)

GE Vernova

Remote

Full-time

Job Description Summary The Regulatory Affairs Lead Licensing Engineer will lead the completion of various regulatory work scopes, including working with GEH / GNF Engineering on major projects for the existing fleet of nuclear reactors. Guided by professional practices and policies that are shaped by the role. The role has moderate autonomy, requiring high levels of operational judgment. Job Description Essential Responsibilities As a Senior Regulatory Affairs Licensing Engineer you will: Coo

Regulatory CMS Senior Manager

Sureminds Solutions

Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig

Principal Systems Engineer

Abbott Laboratories

Pleasanton, California, USA

Full-time

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 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li

Principal Systems Engineer

Abbott Laboratories

Pleasanton, California, USA

Full-time

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 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li

Field Service Engineer 1

GE Healthcare

Remote

Full-time

Job Description Summary Job Summary The Field Service Engineer provides customer site support for all products within their assigned area of responsibility. The FSE serves as the technical liaison between the customer and manufacturing operations. They are responsible for maintaining and repairing equipment on-site and returning it to operational status as quickly as possible while minimizing service costs. This position requires the ability to work independently or in a team environment, must h

Engineering Project Manager III - Standalone Accessories

Russell, Tobin & Associates

Cupertino, California, USA

Full-time, Contract

The Engineering Team at Russell Tobin & Associates is supporting a leading technology company that has an opening for Engineering Project Manager - Standalone Accessories near Cupertino, CA. Responsibilities: Manage end-to-end accessory development (NPI EOL) Lead cross-functional teams (Engineering, Ops, Marketing, CM/OEMs) Own schedules, FAIs, logistics, and configuration (ECOs, BOMs, AML) Ensure trade compliance, consumer safety, and global readiness Drive communication, resolve issues, and

Data Risk Appetite Sr Group Manager, Director

Citi

Remote or New York, New York, USA

Full-time

The Data Risk Appetite Sr Group Manager, Director is a senior level role managing a team responsible for facilitating all aspects of the Enterprise Data Risk and Control Framework and Data Risk Taxonomy. This role is responsible for Quarterly : Top Risk Alignment : Data Risk metricsRisk Appetite AssessmentScenario Analysis and Lessons LearnedData Risk ProfileMetric Adequacy AssessmentRisk Appetite analyticsMetric Maturity AssessmentMetric Coverage of the categoryIssues : thematic analysisLosses

Classification and Trade Data Specialist (Mid-Level or Senior)

Boeing Company

Remote or Dallas, Texas, USA

Full-time

Classification and Trade Data Specialist (Mid-Level or Senior) Company: The Boeing Company The Boeing Company is seeking a Classification and Trade Data Specialist (Mid-Level or Senior) to join their team in Dallas, TX. This role ensures our products are accurately classified for importation and exportation from our nine global warehouse locations. The candidate will have a strong knowledge of aircraft parts classification utilizing the HTS, USML and CCl. Knowledge of import and export regula

Validation Engineer

Katalyst Healthcares and Lifesciences

Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and

Principal Engineer, R&D NPI Lead

Johnson & Johnson

Remote or Jacksonville, Florida, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Senior Process Engineer III

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Responsibilities: Design History File: Ensure that the transferred process is adhering to the Device Master Record. Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities. Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities. Cross-functional Collaboration:

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

New Jersey, USA

Contract, Third Party

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR

Engineer

Katalyst Healthcares and Lifesciences

Los Angeles, California, USA

Full-time

Roles & Responsibilities: 4-6 years Minimum bachelor's or master's degree in a health-care related field Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs. Strong creative, analytical, and problem-solving skills. Proficient in interpreting data and compiling detailed reports. Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes. Expertis

Process Engineer

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules. Responsibilities: Design History File: Ensure that the transferred process is adhering to t

Associate Director - Hematology, Oncology Data Sciences & Digital Health

Johnson & Johnson

Remote or New Brunswick, New Jersey, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Process Engineer

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules.Key Responsibilities: Design History File: Ensure that the transferred process is adhering t

Process Manufacturing Engineer

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Job Description: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules. Responsibilities: Design History File: Ensure that the transferred process is adheri

Lead Human Factors Engineer

Johnson & Johnson

Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Project Manager - IT - II*

HAYS

San Francisco, California, USA

Contract

Project Manager - IT - II* - Contract - San Francisco, CA - $69.86 - $69.86/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is