Regulatory Quality Lead - Medical Device Complaints
LanceSoft Inc
A leading regulatory affairs company in Raritan, New Jersey, is looking for a Customer Quality Specialist. This role focuses on supporting Post Market Regulatory Affairs activities, including complaint handling and regulatory reporting. The ideal candidate should have a Bachelor’s degree and 2-4 years of relevant experience. Key responsibilities involve submitting regulatory reports accurately, collaborating with various stakeholders, and participating in complaint investigations. This position offers opportunities to engage in projects and achieve productivity and accuracy targets. #J-18808-Ljbffr LanceSoft Inc
$94k - $151.8k
...their merit. Job Function: Quality Job Sub Function: Customer/... ...strategic priorities. The Lead, Complaints / Adverse Events is responsible... ...standards and global regulatory requirements are met Ensure... ...experience in the pharmaceutical/medical device/biotech industry, with...QualityRegulatoryComplaintsMedical deviceFull timeWork at officeImmediate start- Overview Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include... ...and complete determination associated Medical Device Report and/or Vigilance Report...QualityRegulatoryComplaintsMedical deviceWork experience placement
$199k - $342.7k
...seeking a Director, Medical Safety Officer (... ...partner with the quality leader and statistical... ...programs and leading in the strategic priority... ..., R&D, Quality, Regulatory, Clinical and... ...on Adverse Events, complaints, and mass communications... ...management of devices in development...QualityRegulatoryComplaintsMedical deviceTemporary workLocal areaFlexible hours$199k - $342.7k
...Director, Medical Safety Officer (MSO) - Biosurgery... ...partner with the quality leader and... ...implementing programs and leading in the strategic... ..., R&D, Quality, Regulatory, Clinical,... ...on Adverse Events, complaints, and mass communications... ...management of devices in development....QualityRegulatoryComplaintsMedical deviceTemporary workLocal areaFlexible hours- ...seeking an experienced Separation PMO Lead/Program Manager to drive end-to-end... ...within a Pharmaceutical or Medical Device organization. This role will lead separation... ...applications, supply chain, finance, HR, regulatory, and quality functions. Manage a large...QualityRegulatoryMedical device
$178k - $307.05k
...Raritan, NJ. This individual will lead a critical, high‑visibility... ..., Tech Ops, Manufacturing, Quality and PMA regulations around... ...&D, manufacturing, quality, regulatory, clinical, commercial,... ...years of experience in the medical device, biotech, or pharmaceutical...QualityRegulatoryMedical deviceFull timeContract workLocal areaImmediate start$79k - $127.65k
...merit. Job Function: Quality Job Sub Function:... ...process product complaints received through various... .... Focus areas are Regulatory Reporting to FDA... ...MED DEV 2.12-1, Device Specific Vigilance... ...as applicable Lead support for regulatory... ...Scientific, Medical, Life Science, Health...QualityRegulatoryComplaintsMedical deviceFull timeApprenticeshipLocal areaImmediate start- The Team Lead is responsible for managing restaurant operations... ...excellent guest service and food quality while ensuring compliance with policies, procedures, and regulatory requirements: Trains,... ...guest questions, concerns and complaints in a timely and professional...QualityRegulatoryComplaintsLocal area
$240k - $265k
...Senior Director, Quality Engineering Combination... ...for all drug-device and biologic-device... ...Essential Functions: Leads and evolves the... ...activities. Oversees complaint handling, device... .... Supports regulatory submissions (IND/NDA... ...in Pharma/Biotech/Medical Device experience,...QualityRegulatoryComplaintsMedical deviceTemporary workLocal areaFlexible hours$109.6k - $150.7k
...Terumo Medical Corporation (TMC) develops, manufactures... ...portfolio of high-quality medical devices used in a broad... ...one of the world's leading medical device manufacturers... ...efficiency, complaint, and customer-focused... ...global and regional regulatory requirements (e.g.,...QualityRegulatoryComplaintsMedical deviceTemporary workLocal areaWorldwide- ...computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate... ...) is a plus. Prior work experience in Medical Device Industry, Biotechnology or Pharmaceutical...QualityRegulatoryMedical deviceWork experience placement
$47 - $52 per hour
...Support product security activities for medical devices, including contributions to FDA... ...premarket guidance and other applicable regulatory standards. Perform threat modeling and... ...oriented with a focus on compliance and quality. Ability to manage multiple priorities...QualityRegulatoryMedical device$22 per hour
...manufacturing/production area to comply with regulatory requirements, good manufacturing... ...operations and/or product inspections medical device manufacturing and other regulated... ...highly preferred, Familiarity with quality standards in production environments...QualityRegulatoryMedical deviceImmediate startDay shiftAfternoon shift- ...Regulatory Affairs Specialist (Hybrid) Hybrid - Warren NJ About Spectrum Vascular Spectrum Vascular is an innovative medical device company focused on vascular access and medication management... ...providing caregivers with high quality, innovative products with...QualityRegulatoryMedical deviceInternshipWork at officeWorldwide
- ...biotechnology company in Raritan, NJ, is seeking a QA Investigations Lead I to provide quality oversight during investigations in a GMP environment. The... ...ensure timely investigations, develop CAPAs, and support regulatory audits. Applicants should have a Bachelor's degree and...QualityRegulatory
$122k - $212.75k
...HR Senior Manager, Quality & Regulatory Affairs DePuy Synthes is recruiting for an HR Sr. Manager, Quality & Regulatory, located in Raynham... ...change leadership. Preferred: Experience in medical devices, healthcare, or other regulated industries. Exposure to...QualityRegulatoryMedical deviceLocal areaImmediate start- ...testing phase of projects, ensuring that software and systems meet quality standards and business requirements. Manage testing... ...Compliance verification: Ensure that software meets GxP standards and regulatory requirements. Regression testing: Conduct regression...QualityRegulatory
- Overview Our client, a leading organization within the cell therapy... ..., GDP, FDA, and applicable regulatory requirements. Support... ...closely with Manufacturing, Quality Assurance, Engineering, Facilities... ..., biotechnology, medical device, or cell therapy manufacturing...QualityRegulatoryMedical deviceFor contractors
$68.05k - $109.87k
...QA Investigations Lead II Legend Biotech is a... ...Lead I as part of the Quality team based in Raritan,... ...product release. Support regulatory inspections and audits... ..., change controls and complaints. Perform analysis... ..., childbirth, related medical conditions and...QualityRegulatoryComplaintsWork experience placementLocal areaWorldwide- ...automation, customer data). Lead cross-functional... ...and architects to ensure high-quality, on-time product delivery.... ...data privacy, security, and regulatory requirements across global markets... ...regulated industries such as medical devices or life sciences. Other...QualityRegulatoryMedical device
$40 - $48.08 per hour
...with industry standards and regulatory requirements. Responsibilities... ...R&D, Product Management, Quality, Marketing & Sales. Interpret... ...is a plus. Knowledge of device product development and prototyping... ...materials, especially in medical devices, is a bonus. Job...QualityRegulatoryMedical deviceContract workTemporary workFor contractorsWork at officeLocal area- A leading life sciences company is hiring a Business Analyst for ECM and Complaints Management. The candidate must possess experience in ECM... ...Incident systems within pharma or medical device environments. Strong testing skills, GxP, and regulatory knowledge are essential. This...RegulatoryComplaintsMedical deviceLong term contract
$130k - $165k
...pharmaceutical, biotechnology, and medical device industries. We serve some of... ...the industry for its high quality deliverables, superior... ...electronically captured data. Lead efforts in writing clear... ...projects. # Follow up on regulatory requirements, industry trends...QualityRegulatoryMedical deviceContract workTemporary workWork at officeRemote workWork from homeWorldwide$25 - $28.17 per hour
...remote Responsibilities Lead the end-to-end development,... ...of industry experience in Medical Device or In Vitro Diagnostics (IVD... ...of IFUs ~ Familiarity with regulatory requirements (IVDR, FDA) ~... ...economically, without compromising quality. System One not only serves...QualityRegulatoryMedical deviceFull timeContract workLocal areaRemote work$130k - $160k
...(NYSE/TSX: BLCO) is a leading global eye health company... ...controls to protect medical products and... ...support of patient safety, regulatory compliance, and operational... ...partners across R&D, Quality, Regulatory Affairs, Manufacturing... ...in medical device or regulated product...QualityRegulatoryMedical deviceTemporary workRemote workWork visa- ...sound laboratory techniques adhering to regulatory, local government, and safety... ...with a Ph.D. • Practical knowledge of medical device regulations. Experience and Skills:... ...in an Analytical Laboratory with GMP or quality control setting is preferred. • Work...QualityRegulatoryMedical deviceLocal area
$164k - $282.9k
...their merit. Job Function: Medical Affairs Group Job Sub... ...finding treatments and cures. We lead where medicine is going and... ...(Medical Affairs, R&D, regulatory, outcomes research, statisticians... ...partners, ensuring timely and high-quality delivery of publication...QualityRegulatoryLocal area$79k - $127.65k
...subject to legal requirements, regulatory approvals and other... ...Specialist is responsible for leading supply chain strategy and execution... ...: Experience in Medical Device, Pharmaceutical, or Biologics... ...Reliability, Project Engineering, Quality Assurance (QA), Science,...QualityRegulatoryMedical deviceContract workLocal areaImmediate start$108k - $165k
...pharmaceutical, biotech, or medical device sectors , along with a proven... ...that meet customer needs. Lead and drive RFI strategy process... ...presentation materials, and quality of responses. Translate RFI... ...this field. Awareness of regulatory landscape, including...QualityRegulatoryMedical deviceContract workTemporary workWork at office$54k - $87.4k
...at jnj.com . Job Function Quality Job Sub Function Quality Systems... ...for executing tasks and leading or supporting projects to progress... ...quality system and current regulatory requirements. Responsible... ...a regulated industry (e.g., medical device, pharmaceutical, or similar)...QualityRegulatoryMedical deviceWork at officeLocal areaRemote work
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