FDA Jobs in Boston, MA

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Product Security Engineer

Vankay Systems

Danvers, Massachusetts, USA

Contract

Role: Product Security Engineer Hiring Mode: Contract (TP) Location: Danvers, MA-01923 [On-site] Skills Matrix Skill Last Used Experience in Years/month Rating (10 points) 1 = newbie 10 = expert Hands on Exp. Yes/No Security risk management techniques Regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR) Pre-market product development activities Medical devices FDA Job Description: 5+ years industry experience in Information Security.Wor

Regulatory affairs - CMC Manager

Sureminds Solutions

Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

Remote

Contract, Third Party

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com

LIMS and QC Applications Consultant

Expedite Technology Solutions

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

Systems Engineer

Mindlance

Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability

Embedded Test Engineer (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools)

Cigniti Technologies Inc

Acton, Massachusetts, USA

Full-time

Job details: Job Role: Embedded tester (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools) Location: Acton, MA Must Have Skill sets:experience in Embedded device /Hardware Testing knowledge Ability to perform whitebox testing, unit testing Hands on experience in mobile app or mobile device testing. Hands on experience in Python/Appium is added advantage. Experience on working, Test Hardware and boards Perform end-to-end functional testing and validation for the application

Consultant, XRPD for Solid Oral dosage, GI

Eliassen Group

Anywhere, US

Contract

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str

Product Security Engineer (Medical devices)

Laiba Technologies LLC

Danvers, Massachusetts, USA

Third Party, Contract

Role: Product Security EngineerLocation: Danvers, MA-01923 [On-site] Security risk management techniquesRegulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR)Pre-market product development activitiesMedical devicesFDA 5+ years industry experience in Information Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR). Experience with security risk managem

Sr. QA Manager

Zachary Piper Solutions, LLC

Chelmsford, Massachusetts, USA

Full-time

Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives. Responsibilities of the Senior Quality Assurance Manager include: Lead quality assurance for two products: balloon pump and balloon catheter. Develop and execute QA strategie

Product Manager

Motion Recruitment Partners, LLC

Boston, Massachusetts, USA

Full-time

This is a medical technology company that specializes in building devices to help patients improve their overall wellbeing and health. They are currently hiring a fulltime Product Manager to work on their transcranial magnetic stimulation (TMS) products. Which is a FDA-cleared for the treatment of depression. The TMS technology uses Magnetic Stimulation aimed at key areas of the brain involved in emotional regulation, cognitive function, and self-control. By activating neural pathways, it helps

Associate Director, Regulatory CMC

IO Associates

Boston, Massachusetts, USA

Third Party

Position Title: Associate Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) Location: Waltham, MA (On-site only) No Third Parties Please! Role Overview: The Associate Director, Regulatory Affairs CMC, is responsible for global CMC regulatory strategies for programs in early and late-stage development through and beyond approval. This position supports clinical registration, commercial development, and manufacturing efforts, as applicable. The role involves collabora

Sycamore SCE Administrator (Statistical Computing Environment)

Virtualan Software

Boston, Massachusetts, USA

Third Party, Contract

Job Title: Sycamore SCE Administrator (Statistical Computing Environment) Location: Hybrid at Boston, MA Job Type: C2C / Full time Overview: We are seeking an experienced Sycamore SCE Administrator to manage and maintain our Statistical Computing Environment (SCE) used for clinical and statistical analysis. The ideal candidate will have deep hands-on experience with the Sycamore platform and a strong background in statistical computing within regulated environments such as pharmaceuticals or lif

Senior Process Engineer

Advantage Technical

Bedford, Massachusetts, USA

Full-time

Position Summary: We are seeking a driven and technically adept Senior Process Engineer with a strong mechanical engineering foundation to join our R&D Hardware Engineering team. This individual will lead cross-functional projects, supporting the development and transfer of innovative medical diagnostic products from concept through to high-volume manufacturing. The ideal candidate is an excellent communicator, a proactive collaborator, and someone who thrives in a fast-paced, highly regulated

Industrial Maintenance Technician

fgf brands

Newton, Massachusetts, USA

Full-time

Job Description: Maintenance Technician "To become the world?s greatest baker, we need the world?s greatest team members!" What FGF Offers: FGF believes in Home Grown Talent, accelerated career growth with leadership training, unleashing your potentialCompetitive Compensation, Health & Welfare Benefits including Vision & Dental and flexible options at competitive premiums401k matching programDiscount program - Restaurants, gyms, shopping, etc.Tuition reimbursement Overview: FGF Brands is growi

Principal Analyst, Crypto Digital Experience

Fidelity Investments

Boston, Massachusetts, USA

Full-time

Job Description: Principal Analyst- Crypto Digital Experience Fidelity Digital Assets (FDA) is dedicated to building products and services that help both institutional and retail clients invest in digital assets and innovate within the increasingly digital world of finance. Fidelity Investments began researching blockchain technology and digital assets solutions in 2014, where years of research and development have provided us with the deep expertise necessary to build the future of finance. A

Product Manager - Medical Devices

Motion Recruitment Partners, LLC

Marlborough, Massachusetts, USA

Full-time

A medical device manufacturer and distributor in Marlborough is looking for talented Product Managers to join their team. They recently launched a novel FDA approved medical device that is being used to treat impulse control, addiction, and depression. This product has the potential to be revolutionary in the mental wellness space. They are looking for Product Managers who hav a strong background in medical device product management with a background either in biology or biomechanical engineeri

Human Factors Engineer

Stellent IT LLC

Andover, Massachusetts, USA

Full-time, Part-time, Contract, Third Party

Title : Human Factors Engineer (Medical Devices) Location : Andover, MA ( Hybrid ) About the job We are seeking an experienced Human Factors Engineer for a 4-month contract. This role requires hands-on experience conducting usability studies with detailed Word reports (not just PowerPoint). The ideal candidate will have a strong background in authoring risk analysis documents, demonstrating proactive communication, and providing active follow-ups. The candidate should be detail-oriented and or

Data Science Engineer

Takeda pharmaceutical

Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Engineer I Product Analysis

Abbott Laboratories

Burlington, Massachusetts, 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

Senior Automation Engineer

Merck KgaA

Bedford, Massachusetts, USA

Full-time

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind