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Document specialist Jobs in Cambridge, MA

Last updated: 17 hours ago
  • Promoted
Document Control Specialist

Document Control Specialist

BRIOHEALTH SOLUTIONS INCBurlington, MA, US
Full-time
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique...Show moreLast updated: 19 days ago
  • Promoted
Document Control Specialist, Contractor I

Document Control Specialist, Contractor I

Integrated ResourcesBoston, MA, United States
Full-time
The processing, tracking and archive of GxP documentation both hardcopy and electronic documentation.QC, process, track, scan, file, label, index, etc. GxP documentation is accurate and complete.Sup...Show moreLast updated: 24 days ago
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  • New!
DOCUMENT PROCESSING

DOCUMENT PROCESSING

Global Channel Management Inc.MA, United States
Full-time
About the job Document Processing.Document Processing needs no experience.Ability to lift up to 20-40 pounds (boxes and mail trays). No Experience needed, will train.Handles Banking and Insurance Do...Show moreLast updated: 17 hours ago
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Document Control Manager - Construction

Document Control Manager - Construction

Turner & TownsendBoston, MA, US
Full-time
From the inception of a project through to completion and beyond, Turner & Townsend help to deliver the outcomes that matter through transformational projects covering the full spectrum of consulta...Show moreLast updated: 6 days ago
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Document Processing Coordinator (Overnight)

Document Processing Coordinator (Overnight)

CooleyBoston, MA, United States
$87,360.00–$126,880.00 yearly
Full-time
Document Processing Coordinator (Overnight).Cooley is seeking a Document Processing Coordinator to join the Document Processing team. The Document Processing Coordinator is responsible for providing...Show moreLast updated: 15 days ago
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Senior Document Control Specialist

Senior Document Control Specialist

CAESWoburn, MA, United States
$78,048.00–$117,072.00 yearly
Full-time
Delivering mission-critical, electronic solutions that protect lives.Use your creativity and critical thinking to take our products from concept to customer. At CAES, we engineer solutions for the w...Show moreLast updated: 1 day ago
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Document Control Manager - AODocs

Document Control Manager - AODocs

Veolia North AmericaBoston, MA, United States
$130,434.00 yearly
Full-time
A subsidiary of Veolia Group, Veolia North America (VNA) offers a full spectrum of water, waste and energy management services, including water, and wastewater treatment, commercial and hazardous w...Show moreLast updated: 2 days ago
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Sales Director, Document Automation (Remote)

Sales Director, Document Automation (Remote)

ExperlogixBoston, MA, US
Remote
Full-time
Why consider this job opportunity : .Opportunity to live and work anywhere within the U.Competitive compensation structure with a focus on growth. Directly report to the VP of Revenue, gaining exposur...Show moreLast updated: 1 day ago
Document ReviewerNEW!

Document ReviewerNEW!

Dutech SystemsBOSTON,Massachusetts, US
$14.23–$17.21 hourly
Individuals need to review scanned document for clarity and orientation.Show moreLast updated: 30+ days ago
Notary Document Signing Specialist. Boston, MA

Notary Document Signing Specialist. Boston, MA

Notary Signing Agent ServicesBoston, MA
Enhance your career as a Notary Document Signing Specialist.This role is ideal for individuals interested in starting a career in the notary field. We’ll provide the necessary tools and training to ...Show moreLast updated: 28 days ago
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Document Processor Specialist

Document Processor Specialist

VirtualVocationsDorchester, Massachusetts, United States
Full-time
A company is looking for a Document Processor / Presentation Specialist.Key ResponsibilitiesDesign and format PowerPoint presentations and handle multimedia requestsCreate and process Excel spreadshe...Show moreLast updated: 6 days ago
Document Reviewer

Document Reviewer

KLDiscoveryMA, United States
$30.00 hourly
KLDiscovery, one of the largest national eDiscovery providers, is currently seeking attorneys who are actively licensed in any. We have an ongoing need for Document Reviewers.Document Reviewers will...Show moreLast updated: 30+ days ago
Document Management Analyst

Document Management Analyst

Cannon SearchBoston, MA, United States
This role supports Intapp applications (Time, Terms, IIS / Boomi) and Litera’s Foundation platform.If you’re passionate about problem-solving, process improvement, and delivering exceptio...Show moreLast updated: 30+ days ago
  • Promoted
Document Control Manager

Document Control Manager

AECOMBoston, MA, United States
Full-time
At AECOM, we're delivering a better world.Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thr...Show moreLast updated: 14 days ago
Document Controller - Construction

Document Controller - Construction

CVS HealthMassachusetts, US
$43,700.00–$107,200.00 yearly
Full-time
Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced...Show moreLast updated: 30+ days ago
  • Promoted
Attorney - Remote Document Review

Attorney - Remote Document Review

Dauntless DiscoveryBoston, MA, US
$26.00 hourly
Remote
Full-time
Experienced Document Review Attorney – Remote.Great opportunity for licensed attorneys with significant document review experience interested in quality focused eDiscovery.Please apply to get on ou...Show moreLast updated: 6 days ago
Document Control Specialist

Document Control Specialist

BRIOHEALTH SOLUTIONS INCBurlington, MA, US
19 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enable chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions is seeking a detail-oriented Document Control Specialist to support the document control and change management processes, as well as the Employee Training Program, within an FDA-regulated 21 CFR Part 820 environment. This role will ensure compliance with U.S. FDA and international regulations through the management of our electronic Quality Management System (eQMS). The Document Control Specialist will collaborate across multiple departments to ensure timely completion of tasks and maintain adherence to regulatory requirements. This is an onsite position located in Burlington, MA, with up to 10% travel required.

Responsibilities

Configuration Management

  • Co-administer the electronic Quality Management System (eQMS) to ensure effective document and change control processes.
  • Support onboarding and training of new employees on eQMS usage.
  • Review change control packets and documents for accuracy, completeness, and compliance.
  • Promote and enforce best practices for configuration management across the organization.
  • Collaborate with teams to facilitate the timely implementation of change control processes.
  • Assist in creating and updating Standard Operating Procedures (SOPs) and forms for configuration management activities.
  • Ensure proper distribution and notification of document releases, revisions, and obsolescence.
  • Adhere to and advocate for adherence to established configuration management procedures.

QMS Training

  • Co-administer the company’s Quality Management System (QMS) training program to ensure ongoing employee compliance.
  • Monitor employee training status, ensuring assignments are completed within designated timelines.
  • Cross-functional Collaboration

  • Drive cross-functional teams to comply with document control and change management policies and procedures.
  • Collaborate with functional departments to understand and address their configuration management needs.
  • Additional Responsibilities

  • Assist Regulatory Affairs with regulatory filings, including Investigational Device Exemptions (IDE), Pre-Market Approvals (PMA), 510(k) submissions, technical files, and design dossiers.
  • Support regulatory inspections and internal audits by providing requested documentation and addressing findings through corrective actions.
  • Stay informed on relevant regulations, guidelines, and industry best practices related to medical device configuration management methodologies (e.g., document / change control, record control).
  • Qualifications

  • 2-4 years of configuration management experience in the medical device industry or other regulated sectors.
  • Exceptional attention to detail, critical thinking, and strong organizational skills.
  • Effective communication skills, with the ability to collaborate across departments and with stakeholders.
  • Skilled in prioritizing tasks and multitasking in a fast-paced environment.
  • Excellent oral and written communication skills.
  • Capable of managing daily tasks independently with minimal supervision.
  • Nice to Have

  • Associate’s or Bachelor’s degree in STEM or Life Sciences.
  • 2-4 years of experience in configuration management for complex electromechanical devices and systems.
  • Familiarity with relevant standards, including FDA QMSR, ISO 13485, and EU MDR.