FDA Jobs in Boston, MA

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Validation Engineer

Kasmo Inc.

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Boston, Massachusetts, USA

Contract

We are seeking a skilled Validation Engineer with experience in smaller technical projects and a proven track record of effective collaboration in team settings and individual roles. Key Competencies and Experience: Project Execution: Demonstrated experience in successfully managing and executing smaller-scale technical projects.Team Collaboration: Proven effectiveness in both team environments and as an individual contributor.Industry Standards: In-depth knowledge of cGMP standards within the p
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Posted 6 days ago

Project Manager

I softcorp

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Boston, Massachusetts, USA

Contract

Role: Project ManagerLocation: Alexion: Seaport HQ, Boston, MAOnsite: 3x a weekContact length: Around 6 month Local candidates only This is what you will do: Developing and implementing global and/or US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. You will be responsible for: Developing and directing innovative and effective regulatory str
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Posted 6 days ago

Sr Manager of Product Management - Medical Aesthetic Devices (Hybrid)

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

This company in the medical aesthetics devices space is looking for a Senior Manager of Product Management to join their team. They provide devices for treatments such as laser hair removal, wrinkle removal, and tattoo removal. This would be a full-time role with a hybrid schedule of 2-3 days/week in their office in Marlborough, MA. In this role, you will work very closely with engineering teams, marketing, regulatory, R&D, and more to lead the full end-to-end product management process for both
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Posted 32 days ago | Updated 7 hours ago

Senior Software Engineer- Medical Devices

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Job Description A medical device manufacturer in Boston is hiring a Senior Software Engineer to their team. As a Senior Software Engineer, you'll be hands on in the development, testing, and design of applications that are used to build critical medical devices used during surgeries. This role is a full-time direct hire and is three-days onsite in downtown Boston. The company specializes in the development and manufacturing of energy-based medical devices that are used during aesthetic procedure
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Posted 26 days ago | Updated 7 hours ago

Senior Human Factors Engineer

Motion Recruitment Partners, LLC

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Raynham, Massachusetts, USA

Full-time

A leader in the medical devices and robotics industry is seeking a multi-faceted, talented, user-centered Senior Human Factors Engineer who is driven to make people's quality of life better through compelling, elegant, and intuitive design experiences. For the better part of a century, this group has been focusing on improving surgery procedures and health outcomes across the world. They have a specialty in surgical technologies, orthopedics and interventional solutions, and are driven to impro
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Posted 17 days ago | Updated 7 hours ago

Biostatistician (Part-Time)

Apex Systems

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Watertown, Massachusetts, USA

Full-time

Job#: 2032292 Job Description: Biostatistician (Part-Time) 2032292 Location: Watertown, MA (Hybrid/Remote 20-30hrs/week) Science: Small Molecule Therapeutic Area: Oncology Job Overview: Our Watertown-based biopharmaceutical client is seeking an experienced Biostatistician who can provide statistical support on clinical development programs and/or clinical trials. Primary Job Requirements:At least 5 years of experience in oncology drug development in industry, with a strong preference for exper
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Posted 9 days ago | Updated 11 hours ago

(Sr.) Clinical Trial Manager

Apex Systems

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Watertown, Massachusetts, USA

Full-time

Job#: 2032419 Job Description: Sr. Clinical Trial Manager 2032419 Location: Watertown, MA (Hybrid/Remote) Science: Small Molecule Therapeutic Area: Oncology Job Overview: This role entails managing oncology clinical trials from inception to Phase , overseeing strategy, coordination, and compliance with timelines, budget, and standards. Primary Job Responsibilities:Oversee the comprehensive management of clinical trial execution, ensuring adherence to budget, timelines, and quality benchmarks, w
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Posted 9 days ago | Updated 11 hours ago

Production Associate II (Multiple Openings)

Johnson & Johnson

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Danvers, Massachusetts, USA

Full-time

Description Abiomed, part of the Johnson & Johnson Family of Companies is recruiting for a Production Associate II to be located in Danvers, MA. About Johnson & Johnson 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 unique
Posted 24 days ago | Updated 9 hours ago

Principal Systems Engineer

Medtronic

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Boston, Massachusetts, USA

Full-time

Position Description: Principal Systems Engineer for Covidien LP (a Medtronic company) located in Boston, MA. Responsible for technical functions to advance existing technology or introduce new technology and therapies. Provide Electrical Engineering (EE) support related to the regulatory requirements of different countries for Class II and Class medical devices; responsible for GEO expansion by providing Systems Engineering support to release new products to new Geographies; responsible for C
Posted 26 days ago | Updated 2 days ago

Sr Software Test Engineer - Surgical Operations

Medtronic

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Boston, Massachusetts, USA

Full-time

Careers that Change Lives In this role, you will join a world class team of mechanical, electrical and software engineers responsible for further development and enhancement of the globally launched Robotic Assisted Surgery platform within the Surgical Operating unit: ;br> Medtronic's Surgical Operating Unit is one new, powerful operating unit bringing together the people and product portfolio of Surgical Robotics and Surgical Innovations. With the Medtronic Mission as our North Star, we will bu
Posted 26 days ago | Updated 2 days ago

Senior Regulatory Affairs Specialist

Johnson & Johnson

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Danvers, Massachusetts, USA

Full-time

Description Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicia
Posted 2 days ago | Updated 9 hours ago

Senior Human Factors Engineer - Greater Boston

Motion Recruitment Partners, LLC

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Raynham, Massachusetts, USA

Full-time

This role is with a large medical device client of ours based in Raynham, MA. They are looking to hire a Human Factors Engineer with strong experience in the medical device industry. This person would be working in their oxygenation department overseeing some of their products in this space working cross functionally with R&D, design, engineering, and stakeholders. This is a 12-month contract role that is also hybrid in Raynham, MA and would require you to come onsite three times a week. Requir
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Posted 16 days ago | Updated 7 hours ago

Principal Regulatory Affairs Specialist

Medtronic

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Boston, Massachusetts, USA

Full-time

Principal Regulatory Affairs Specialist - Surgical The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the current product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the concept phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regula
Posted 17 days ago | Updated 2 days ago

Regulatory Affairs CMC Officer

Danaher Corporation

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Marlborough, Massachusetts, USA

Full-time

Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and the
Posted 26 days ago | Updated moments ago

Supply Chain Systems Analyst II

Johnson & Johnson

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Danvers, Massachusetts, USA

Full-time

Description Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Ab
Posted 4 days ago | Updated 9 hours ago

NPI Operations Manager

Johnson & Johnson

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Danvers, Massachusetts, USA

Full-time

Description Abiomed is recruiting for an NPI Operations Manager, located in Danvers, MA. 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
Posted 20 days ago | Updated 9 hours ago

Design Assurance Engineer

Motion Recruitment Partners, LLC

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Woburn, Massachusetts, USA

Full-time

Our client is a leading innovator in the healthcare industry, specializing in the development and production of cutting-edge medical devices. Their mission is to improve patient outcomes and quality of life through advanced technology and rigorous quality standards. They are seeking a highly skilled and detail-oriented Design Assurance Engineer to join their team. In this role, you will be responsible for ensuring the quality and compliance of our medical device designs throughout the product de
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Posted 53 days ago | Updated 7 hours ago

Machine Operator 1

Johnson & Johnson

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Raynham, Massachusetts, USA

Full-time

Description Johnson & Johnson is currently seeking a Machine Operator I in Raynham, MA. 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
Posted 2 days ago | Updated 9 hours ago

Process Development Extrusion Engineer II

Medtronic

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Beverly, Massachusetts, USA

Full-time

Careers that Change Lives In this exciting role as a Process Development Engineer II, you will have responsibility for developing catheter extrusion and other related processes. The Danvers Extrusion center of excellence is one of the largest polymer processing plants in the medical device industry with over 30 active extrusion lines. Medtronic helps patients all over the globe to alleviate pain, restore health, and extend life. This role reports to the product development manager and works i
Posted 26 days ago | Updated 2 days ago

Director, Quality Systems (eQMS Veeva)

Apex Systems

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Cambridge, Massachusetts, USA

Full-time

Job#: 2019758 Job Description: Director, Quality Systems (eQMS Veeva) 2019758 Location: Boston,MA(Hybrid / Onsite) Therapeutic Area: Small molecule Pharma Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance. Primary Job Responsibilities: Ensure compliance with cGXP regulations by evaluating and advancing quality
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Posted 30 days ago | Updated 11 hours ago