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
- ...DescriptionOVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These... ...complete determination associated Medical Device Report and/or Vigilance Report •...QualityRegulatoryComplaintsMedical deviceWork experience placement
- Hunter Recruiting is seeking a Quality Specialist to support and maintain the Quality Management System for medical device, pharma and combination device sterilization operations... ...and incoming inspection to ensure regulatory compliance. The ideal candidate has a Bachelor...QualityRegulatoryMedical device
$94k - $151.8k
...Johnson is recruiting for a Lead Analyst, Contract Management... ...solutions to improve execution quality and speed.Cross-Functional... ...required with J&J or medical devices, pharmaceuticals, or the legal... ...Administration, Problem Solving, Regulatory Compliance, Relationship...QualityRegulatoryMedical deviceFull timeContract workTemporary workWork at officeLocal area- ...26-01179Remote50% RemoteSummary: Our client is a leading medical device company and is seeking an experienced CAPA Program Lead to lead a high-priority quality remediation initiative supporting medical device regulatory compliance. This consultant will assess existing...QualityRegulatoryMedical device
$43.5k - $69.58k
...all safety, environmental and quality policies/ procedures.... ...product issues and customer complaints. Hands‑on knowledge of Empower... ...Compendia, FDA, ICH and other regulatory agency requirements. How you... ...down the aisle. It enables medical devices that help a little boy hear...QualityRegulatoryComplaintsMedical deviceFull timeFor contractorsWork at officeLocal areaFlexible hours$184k - $230k
...has a long history in quality manufacturing of... ...Director, Compliance leads the day-to-day design... ...Compliance member of the Medical, Legal, and Regulatory review committee;... ...-event / product-complaint capture procedures relating... ..., or medical-device industry, including...QualityRegulatoryComplaintsMedical deviceContract workTemporary workFor contractorsFixed term contractWork at officeFlexible hours3 days per week$164k - $282.9k
...MedTech to support our handheld medical devices business. This role will be... ...Development (NPD) will lead a multi‑disciplinary team... ...strategy, project execution, regulatory and quality readiness, and cross‑... ...time to stable production, complaint rates), budget adherence, and...QualityRegulatoryComplaintsMedical deviceLocal areaImmediate startRelocation packageFlexible hours3 days per week- ...Job Description The Quality Systems Manager is responsible for leading the development, implementation... ...with applicable regulatory requirements, industry... ...system issues. · Complaints, deviations, nonconformances... ...industry (e.g., medical device, manufacturing) · Experience...QualityRegulatoryComplaintsMedical device
- ...Complaints Specialist Spectrum Vascular is an innovative medical device company focused on vascular access and medication management... ...caregivers with high quality, innovative products with exceptional... ...with company policies, regulatory requirements, and industry standards...QualityRegulatoryComplaintsMedical deviceWork experience placementImmediate startWorldwide
- 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... ..., PACE, SMBD, Regulatory and Quality,... ...forwarding of customer complaints (i.e. adverse events...QualityRegulatoryComplaintsMedical deviceTemporary workWorldwideLong distanceNight shift
$134k - $185k
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... ..., market research, regulatory, legal and any issue... ...of customer complaints (i.e. adverse events...QualityRegulatoryComplaintsMedical deviceTemporary workWork at officeWorldwideFlexible hoursNight shift- ...The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role... ...processes while maintaining regulatory compliance. Responsibilities Manage...QualityRegulatoryMedical deviceContract work
- ...cross-functional teams, and ensure regulatory documentation is developed,... ...applicable Design History Files (DHF) leading to the implementation of MDR-compliant... ...or a related field. Experience in medical device R&D, regulatory, or quality roles. Proven experience leading...QualityRegulatoryMedical device
$94k - $151.8k
...Synthes Orthopaedics is recruiting for a Lead Analyst, Contract Management, to join... ...related business experience within the medical devices, pharmaceuticals, or legal field.Strong... ...representative bodies, as may be required, regulatory approvals and other customary...RegulatoryMedical deviceFull timeContract workWork at officeLocal areaImmediate start- ...will be responsible for leading and supporting one or... ...discussions with regulatory agencies/ notified bodies... ...clinical studies to provide quality deliverables while... ..., MEDDEV) Clinical/medical background a + Experience... ...projects a + Medical device experience highly...QualityRegulatoryMedical deviceFor contractorsInterim roleLocal area
- ...involving inhalation powder products and medical devices, partnering with external... ...How You Will Make An Impact Lead strategic sourcing initiatives for... ...for cost reduction while balancing quality, supply continuity, regulatory requirements, and business needs....QualityRegulatoryMedical deviceContract work
$53 - $63 per hour
...staffingfuture.comPosition Summary: · Provides quality oversight of GxP computerized systems... ...compliance with FDA, EMA, and ICH regulatory requirements in support of patient safety... ...Quality, Internal/External Audit, and Quality Complaints. · Contributes to the organization’s...QualityRegulatoryComplaints- ...Function: QualityJob Sub Function: Quality SystemsJob Category:... ...current business processes and regulatory requirements.You will act as... .... In addition, you will lead or contribute to projects within... ...such as pharmaceuticals, medical devices, or diagnostics. You have strong...QualityRegulatoryMedical deviceFull timeLocal area
- ...Inc. is recruiting for a 2nd shift Engineering Technician to drive regulatory-compliant process development in pharmaceutical and medical device projects. The role requires collaboration with Quality, Regulatory, Manufacturing, Supply Chain, and Operations to plan, schedule...QualityRegulatoryMedical deviceAfternoon shift
$171.12k - $256.68k
...Summary The Study Delivery Lead (SDL) leads the cross functional... ...trial with consistency, quality and per planned timelines. The... ...of data is suitable for regulatory submission. The SDL collaborates... ...a pharmaceutical company, a Medical device/Diagnostic company, Academic...QualityRegulatoryMedical deviceContract workLocal area- ...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
$28 - $31 per hour
...Quality Assurance Associate Staff Management Group is seeking... ...meet established quality and regulatory requirements. This role assists... ...release activities, product complaints, recalls and field alerts,... ...Group is one of New Jersey's leading staffing and recruiting agencies...QualityRegulatoryComplaintsContract workWork at officeDay shift- ...a 2nd shift Engineering Technician ensuring pharmaceutical and medical device process development projects are completed on time and within scope and budget while meeting all technical, quality, regulatory, and safety requirements. Develop project plans, schedules, and...QualityRegulatoryMedical devicePermanent employmentAfternoon shift
- Legend Biotech, based in Somerset, NJ, seeks a Site Quality Compliance Lead for the Raritan CARVYKTI facility to steer regulatory compliance and audit readiness in a GMP environment. The role leads through influence in a matrixed Legend/J&J setting, driving continual improvement...QualityRegulatory
$122k - $212.75k
...business units—including R&D, Operations, Quality, and Marketing—are engaged as key... ...senior stakeholders in R&D, Operations, Regulatory, and Quality.Ensure the supplier support... ...technologies, and supply markets, ideally within medical devices, pharma, or life sciencesFamiliarity...QualityRegulatoryMedical deviceFull timeContract workTemporary workLocal area$164k - $282.9k
...recognize their merit.Job Function: Medical Affairs GroupJob Sub Function... ...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...QualityRegulatoryFull timeLocal area$122k - $212.75k
...bodies, as may be required, regulatory approvals and other customary... .... Key Responsibilities Lead and govern a portfolio of SC... ...Manufacturing, Planning, Procurement, Quality, R&D, and Commercial) to... ...within a regulated medical device environment. Qualifications...QualityRegulatoryMedical deviceFull timeImmediate start- ...including R&D, Operations, Supply Chain, Quality, and Marketing—are engaged as key... ...stakeholders in R&D, Operations, Supply Chain, Regulatory, and Quality.Partner with Design and... ..., and supply markets, ideally within medical devices, pharma, life sciences or FMCG (fast moving...QualityRegulatoryMedical deviceFull timeContract workTemporary workLocal area
$175k - $210k
...pharmaceutical, biotechnology, and medical device industries. We serve some of... ...and Taipei, Taiwan. Quality is our backbone, customer-... ...performance evaluation process. Lead statistical and programming... ...statistical methodology and regulatory requirements. Validate...QualityRegulatoryMedical deviceContract workTemporary workWork at officeRemote workWork from homeWorldwide- ...health issues today and address the medical challenges of tomorrow. We... ...Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the... ...regulatory product strategy and the Quality Dossier Program (QDP)....QualityRegulatoryMedical deviceLocal area
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