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
...merit. Job Function: Quality Job Sub Function:... ...strategic priorities. The Lead Complaints / Adverse Events is... ...quality standards and global regulatory requirements are met ~... ...experience in the pharmaceutical/medical device/biotech industry with...QualityRegulatoryComplaintsMedical deviceFull timeWork at officeImmediate start- ...compliance, legal and regulatory guidelines. A TLL... ...in Marketing, Medical Affairs, Sales, and... ...as directed in a complaint manner. Act as a liaison... .... Execute and lead specific TLL... ...pharmaceutical or medical device industry GI and/or... ...including high-quality healthcare,...QualityRegulatoryComplaintsMedical deviceWork experience placementWork at officeLocal areaRemote workHome office
- 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
$137k - $235.75k
...find treatments and cures. We lead where medicine is going and... ...oversight for consequential regulatory, partner-selection,... ...significant strategic, regulatory, quality, budget, partner, or timeline... ...biotechnology, diagnostics, medical‑device, or clinical‑laboratory experience...QualityRegulatoryMedical deviceContract workLocal area- ...Spectrum Vascular is an innovative medical device company focused on vascular... ...caregivers with high quality, innovative products with exceptional... ...mindset. The Complaint Specialist is responsible for... ...accordance with company policies, regulatory requirements, and industry...QualityRegulatoryComplaintsMedical deviceWork experience placementImmediate startWorldwideFlexible hours
- ...serving the Pharmaceutical, Medical Device, Biotech, and IT... ...staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing... ...Device Safety team members. Lead assigned safety projects... ...medical device adverse events, complaints, and device deficiencies....QualityRegulatoryComplaintsMedical deviceRemote work
$53.03 - $56.81 per hour
...56.81/hr. Role: Siemens Polarion Lead Product Analyst Job Description :... ...The contractor will partner with R&D, quality, regulatory, systems engineering, and technology teams... ...or more years of experience in the medical device or another regulated industry. Hands...QualityRegulatoryMedical deviceContract workFor contractors- ...Description Job Description: Siemens Polarion Lead Product Analyst Location: Raritan,... ...Management, Risk Management, PLM, Medical Device R&D Desirable Skills: Windchill... ...environment. Partner with R&D, Quality, Regulatory, Systems Engineering, and IT teams to...QualityRegulatoryMedical deviceContract work
- ...availability, high quality and proper... ...market research, regulatory, legal and any issue... ...updates and creating/leading marketing advisory... ...team. Partner with Medical Affairs team including... ...of customer complaints (i.e. adverse events... ...management in the medical device industry including...QualityRegulatoryComplaintsMedical deviceWork at officeRemote workFlexible hours
- ...customized talent solutions to the Biotechnology, Pharmaceutical & Medical Device markets. Our commitment to excellence ensures that we... ...with Process Development, MSAT, Manufacturing, Quality, Regulatory, and Supply Chain teams Support technical documentation...QualityRegulatoryMedical device
- ...in the Pharmaceutical, Biotechnology, or Medical Device industry - 5+ years in System... ...Ability to work collaboratively in teams, lead projects, or work independently Experience... ...reviews, and escalate issues to Technology Quality Management #J-18808-Ljbffr TechDigital...QualityMedical deviceRemote work
- ...Johnson MedTech is recruiting for a Project Lead, Innovation & Partnerships in Medtech. The role... ..., drive program execution, and align regulatory, quality, and manufacturing activities to bring complex medical devices from concept to market. #J-18808-Ljbffr Johnson...QualityRegulatoryMedical deviceFlexible hours
- ...Raritan, NJ is seeking a Senior Manager, Quality Strategy to shape and execute the integrated... ...strategy across QA, QS, and QC. You will lead strategy and governance for quality... ...site, partner with leadership, and drive regulatory readiness. The role requires 8+ years in...QualityRegulatory
- ...cross-functional teams, and ensure regulatory documentation is developed,... ...applicable Design History Files (DHF) leading to the implementation of MDR-compliant... ...a related field. Experience in medical device R&D, regulatory, or quality roles. Proven experience...QualityRegulatoryMedical device
- ...Engineer, Site MSAT, in Raritan, NJ, for a 12-month hybrid engagement. You will lead dual sourcing programs for lentivirus materials, coordinate with global teams, and ensure quality and regulatory compliance across projects. Responsibilities include vendor assessments,...QualityRegulatory
$109k - $174.8k
...and recognize their merit. Job Function Regulatory Affairs Group Job Sub Function... ...for a Senior Regulatory Affairs Program Lead to support our Wound Closure and Healing... ...support new, modified and currently marketed medical devices. He/she guides conformance with...RegulatoryMedical deviceLocal areaImmediate startRemote work- ...the Technical Operations team in Raritan, NJ. The role leads moderate- to high-complexity quality investigations related to manufacturing, facilities, and validation, delivering robust reports, CAPAs, and regulatory-aligned outcomes. The candidate will collaborate with...QualityRegulatory
$110k - $123k
...Job Description The Quality Assurance Engineer II... ...target. Keep customer complaints less than or equal to... ...understanding of GD&T · Leads investigations to... ...SOPs Assists with regulatory audits Performs... ...employees, including medical, dental and vision...QualityRegulatoryComplaintsMedical device$175k - $210k
...pharmaceutical, biotechnology, and medical device industries. We serve some of... ...the industry for its high-quality deliverables, superior... ...performance evaluation process. Lead statistical and programming... ...statistical methodology and regulatory requirements. Validate...QualityRegulatoryMedical deviceContract workTemporary workWork at officeRemote workWork from homeWorldwide$170k - $205k
...pharmaceutical, biotechnology, and medical device industries. We serve some of... ...the industry for its high-quality deliverables, superior... ...to clients, or submitted to regulatory agencies. These QC activities... ...demonstrated experience and success in leading statistical programming...QualityRegulatoryMedical deviceContract workTemporary workWork at officeRemote workWork from homeWorldwide- ...Bridgewater, NJ seeks Investigator II to independently lead moderate- to high-complexity quality investigations across manufacturing, facilities,... ...based thinking to drive root-cause analyses, CAPAs, and regulatory-ready reports, while ensuring compliance with site procedures...QualityRegulatory
- ...combination products and/or medical devices. The applicant should have experience... ...controls, and be able to lead and conduct FMEAs. Specific... ..., manufacturing, and quality groups to develop Product Risk... ...development processes, cGMPs and regulatory requirements are required....QualityRegulatoryMedical device
$80k - $116k
...worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-... ...is known in the industry for its high-quality deliverables, superior customer service... ...(WIs), industry data standards, regulatory requirements, and trial Sponsor-specific...QualityRegulatoryMedical deviceContract workTemporary workWork at officeRemote workWork from homeWorldwide- Eurofins Scientific is seeking a Sample Extraction Manager for Medical Device studies in South Brunswick, NJ. You will oversee extraction... ...instructions, and maintaining accurate documentation to support regulatory submissions. Excellent leadership and communication are...RegulatoryMedical device
- Legend Biotech US in Raritan, NJ is seeking a Manufacturing Lead Operator for Aseptic Process to join the Manufacturing &... ...purification, aseptic processing, and data recording while ensuring quality, safety, and regulatory compliance across ISO 5 and ISO 7 environments. #J-18808-...QualityRegulatoryShift work
$109k - $174.8k
...disease. Our Shockwave Medical portfolio aims to... ...standard of care for medical device treatment of... ...Company meets statutory and regulatory requirements relating... ...border interactions Lead the development and management... ...Skills Communication, Complaints Investigation,...RegulatoryComplaintsMedical deviceInternshipWork at officeLocal areaImmediate start$178k - $307.05k
...External Manufacturing Regulatory Compliance... ...Director works across Quality External... ...implications. Lead through influence... ...material suppliers device and combination-product... ...inspections deviations complaints remediation regulatory... ...advanced therapy medical device or...QualityRegulatoryComplaintsMedical deviceFull timeContract workLocal areaImmediate start$109k - $174.8k
...modalities to finding treatments and cures. We lead where medicine is going and need... ...that impact the efficiency, timeliness, and quality of deliverables, and provides leadership,... ...principles is preferred. Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant...QualityRegulatoryLocal areaImmediate start- ...Job Description Position - Lead Architect — Enterprise Ansible Automation (CIQ... ...architecture, the migration approach and the quality of everything the team delivers. You... ...\n \n Experience in pharmaceutical, medical device or other regulated industries (GxP, CSV,...QualityMedical deviceLive in2 days per week3 days per week
- ...alignment with business objectives, regulatory requirements, and operational... ..., Planning, Procurement, and Quality processes, as well as proven experience leading cross-functional teams to... ...environments, preferably within Medical Devices, Pharmaceuticals, Life Sciences...QualityRegulatoryMedical device
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