fdma Jobs in boston, ma

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Director, Device Engineering

Gilead Sciences, Inc.

Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Director Contract Research Organization (CRO) SME (Customer Success)

Saama Technologies, LLC

Remote

Full-time

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi

Product Owner/Manager- Medical

INSPYR Solutions

Remote or Santa Clara, California, USA

Contract

About the Role We are seeking an experienced and driven Product Owner/Manager with a strong background in medical hardware product development . This role is critical in bridging the gap between clinical needs, engineering, regulatory requirements, and market demands to ensure delivery of high-impact, safe, and effective medical devices. The ideal candidate will possess a deep understanding of the medical hardware lifecycle, from concept through commercialization, including regulatory pathways (

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

Principal Engineer, Autonomy Interface Software

General Motors

Remote

Full-time

Job Description Remote : This role is based remotely but if you live within a 50-mile radius of Mountain View, you are expected to report to that location three times a week, at minimum. Role: The Principal Software Engineer at General Motors should be an experienced leader who cares deeply about software and software quality. As a Principal Software Engineer, you will be responsible for designing, documenting, and implementing complex, highly scalable, low-latency software in C++ on high perf

ETL Developer | Remote | Contract

Walker Healthforce

Remote

Contract

ETL Developer | 2+ years of experience | Remote | 24 month contract Walker Healthforce is seeking an experience ETL Developer with 2+ years of experience in healthcare IT to support a public client's Transformed Medicaid Statistical Information System (T-MSIS). This is a 2-year contract with potential for extension. START DATE:ASAP CONTRACT LENGTH:24-months RATE RANGE:$40-$50 (negotiable, not guaranteed, based on qualifications) LOCATION:Remote CORE REQUIREMENTS: - 2 years as an ETL Developer

Engineer III, Validation

Thermo Fisher Scientific

Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Field Service Engineer I (ImmunoDiagnostics) - Tampa or Orlando, FL

Thermo Fisher Scientific

Remote or Tampa, Florida, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. At Thermo Fisher Scientific, each one of our 100,000 plus extraordinary minds has a unique story to tell

Staff R&D Engineer, Life Cycle Management

Johnson & Johnson

Remote or Raritan, 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

Data Management Sr Manager

Aditi Consulting

Remote or Thousand Oaks, California, USA

Contract

Payrate: $55.00 - $60.00/hr. Summary: To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes. Responsibilities: Develop Data Management playbook to encompass new ways of working with key accountabilities defined and known, both internally within function as well as broader study team Assess and determine roles and responsibilities within the Data Management Team Cleans

Sr. Mechanical Engineer, Hardware Simulation

Johnson & Johnson

Remote or 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

Senior Engineer, R&D Compliance

ICU Medical, Inc.

Remote

Full-time

Job Description Position Summary This position is responsible for leading regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with global medical device standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, and ISO 14971. Essential Duties & Responsibilities Material Compliance & Restricted Substances: Lead and manage EU MDR-related DHF remediation activities with a focus on legacy material compliance and regulatory gap assessments. Au

Senior Manager, Data Analytics

Quest Diagnostics Inc.

Remote or Wood Dale, Illinois, USA

Full-time

Overview Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a highly vi

Staff Product Security Engineer

Johnson & Johnson

Remote or Cincinnati, Ohio, 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

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Software Engineer L6 - Server Platform Architect

Netflix, Inc.

Remote

Full-time

Netflix is one of the world's leading entertainment services, with over 300 million paid memberships in over 190 countries enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywhere, and can change their plans at any time. Open Connect (OC) is a critical group within Netflix that builds and manages a content delivery network (CDN) that delivers all of Netflix's streaming video. In additio

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye

Data Scientist Sr. Advisor

General Dynamics

Maryland, USA

Full-time

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: MBI (T2) Job Family: Data Science Job Qualifications: Skills: Data Science, Machine Learning, Python (Programming Language) Certifications: None Experience: 10 + years of related experience ship Required: No Job Description: GDIT is seeking a skilled Data Scientist Sr. Advisor with experience supporting federal health or commercial agencies,

Principle Software Development Engineer

Bayer Corp

Remote or Indianola, Pennsylvania, USA

Full-time

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of br

Senior Manager Systems Engineering

Johnson & Johnson

Remote or Cincinnati, Ohio, 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