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
- ...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
- ...The Regulatory Affairs Sr. Associate is an experienced medical device regulatory professional who can independently... ..., where appropriate, lead regulatory activities... .... Partner with Quality, Clinical/Medical Affairs... ...Support Support complaint, adverse event,...QualityRegulatoryComplaintsMedical deviceWork at office
- Sr. Quality Manager--Device & Packaging This role is 100% Onsite Work Schedule... ...products according to Client and regulatory specifications and... ...Agreements. Approve product quality complaint investigations. Review and... ..., biologics, or medical devices). #J-18808-Ljbffr...QualityRegulatoryComplaintsMedical deviceContract workWork experience placementLocal areaMonday to Friday
$40 - $47 per hour
...are seeking a detail-oriented Quality Compliance Specialist to... ...readiness, internal audits, and regulatory inspections. ~Support... ...quality investigations, product complaints, and continuous improvement... ...biotechnology, pharmaceuticals, medical devices, or advanced therapies is a...QualityRegulatoryComplaintsMedical deviceHourly payContract workFreelance$96.4k - $132.55k
...Company: Terumo Medical Corporation Department... ...portfolio of high-quality medical devices used in a broad range... ...one of the world's leading medical device manufacturers... ...case support, regulatory compliance, and the... ...products, reporting device complaints when appropriate,...QualityRegulatoryComplaintsMedical deviceTemporary workRemote workWorldwideHome officeLong distanceNight shift$134k - $185k
...receive an alert: Terumo Medical Corporation (TMC)... ...portfolio of high-quality medical devices used in a broad range... ...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- ...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
- ...additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required... ...is not present. Reports disciplinary issues and customer complaints to management. External Basic Qualifications One year...RegulatoryComplaintsWork experience placementSeasonal workLocal areaShift work
- ...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
- ...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
$84.6k - $157.2k
...yourself, embraced for the unique qualities you bring. Our culture... ...s what makes us Roche. As a Regulatory Affairs Project Manager you... ...live in the spirit of "We all lead" using VACC principles. You... ...Regulatory Affairs for IVD/Medical Device preferred. You can manage high...QualityRegulatoryMedical deviceLive inLocal areaRelocation packageShift work- ...We’re looking for an onsite Quality Control Manager for our plant... ...partnering closely with operations, leading a team of inspectors and... ...Ensure compliance with regulatory, customer, and internal standards... ...minimal findings Reduced customer complaints and internal defects A...QualityRegulatoryComplaints
- ...work closely with team members and assist in training, regulatory audits, and process improvements. The successful... ...or Science and at least three years of experience as a Lead Engineer. Benefits include medical, dental, and vision insurance, along with a 401(k) plan...QualityRegulatory
- ...Years Benefits: PTO, paid holidays, BCBS medical plans, vision/dental plans, 401(k),... ...solutions while ensuring compliance with quality, regulatory, and operational requirements. The ideal... ...collaboration within a medical device, pharmaceutical, or similar regulated industry...QualityRegulatoryMedical device
$106k - $197k
...yourself, embraced for the unique qualities you bring. Our culture... ...us Roche. At Roche Global Regulatory Affairs we strive to be the... ...execution and follow up. You lead the organization to adapt to... ...degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical...QualityRegulatoryMedical deviceLocal areaRelocation package- ...Commerce Cloud (Hybris) expertise to lead Agile delivery for B2B digital... ...and the ability to drive high-quality, compliant solutions aligned with business and regulatory requirements. The ideal... ...Experience in Life Sciences / Medical Device domain Knowledge of regulatory...QualityRegulatoryMedical device
- 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
$90k - $130k
...pharmaceutical, biotechnology, and medical device industries. We serve some of... ...the industry for its high quality deliverables, superior... ...support to client audits and regulatory inspections. Follow up on audit... ...and a desire to excel in leading data management projects....QualityRegulatoryMedical deviceContract workTemporary workWork at officeRemote workWork from homeWorldwide- ...pharmaceutical, biotechnology, and medical device industries. We serve some of... ...the industry for its high quality deliverables, superior... ...to the Clinical Operations Lead or designee for review and approval... .../audits conducted either by regulatory authorities, Sponsors, or...QualityRegulatoryMedical deviceContract workInterim roleLocal areaRemote workWorldwide
- ...is seeking a Global Viral Vector MSAT Lead as part of the Global Manufacturing & Supply... ...Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams to enable... ...including pregnancy, childbirth, related medical conditions and lactation), gender identity...QualityRegulatoryPermanent employmentFull timeFor contractorsLocal areaWorldwide
- ...standards. Ideal candidates should have at least three years of manufacturing experience in the Pharmaceutical or Medical Device industry, a committed approach to quality and detail, and the ability to effectively manage resources across multiple shifts. #J-18808-Ljbffr Merck...QualityMedical deviceShift work
- ...Role: Regulatory Affairs Associate Location: United States Duration: Long Term contract... ...Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology... ...internal stakeholders. Collaborate with Quality Assurance, R&D, Clinical, Manufacturing...QualityRegulatoryMedical deviceLong term contract
$102k - $177.1k
...; West Chester, PA; Warsaw, IN. Goal: Lead sourcing and supplier performance management... ...continuous improvement. Partner with Quality/Regulatory stakeholders for supplier... ...Preferred: Experience in a regulated MedTech/medical device environment. Exposure to network optimization...QualityRegulatoryMedical deviceLocal areaImmediate start$50k - $82k
...with internal teams (Sales, Service Centers, Distribution, Quality, Clinical, Regulatory, Legal, Finance) and external vendors to ensure smooth... ...preventive maintenance schedules, urgent delivery programs, and complaint investigations. Handle invoicing, purchase orders,...QualityRegulatoryComplaintsWork at officeAll shiftsNight shift$150k - $200k
...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... ...of-the-art statistical methodology and regulatory requirements. Validate core...QualityRegulatoryMedical deviceRemote jobContract workTemporary workWork at officeWork from homeWorldwide$124k - $174k
Colgate is seeking a Regulatory Affairs Project Manager in Piscataway, New Jersey. This hybrid position leads global regulatory submissions and ensures compliance with quality management systems. The ideal candidate has at least seven years of experience in regulatory...QualityRegulatoryMedical device- Overview Hiring: Business Analyst - ECM / Complaints Management (GxP & Testing) Seeking an... ...within Life Sciences / Pharma / Medical Device environments. Location Location: Raritan... ...requirements, BRD/FRD, RTM) Nice to Have Quality/Manufacturing systems (CAPA, deviations...QualityComplaintsMedical deviceLong term contractImmediate start
$109.5k
...today and address the medical challenges of tomorrow... ...and procedures. Ensures quality and effectiveness of... ...analysis. Designs and leads complex experiments,... ...problems; integrates regulatory and operational needs;... ...health care, medical devices, pharmaceutical, biologics...QualityRegulatoryMedical deviceLocal area- ...Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since... .... Job Description Description: The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report...QualityRegulatoryMedical device
$130k - $160k
...mission forward. As a global medical technology leader for... ..., Virginia Site Quality leader and Management Representative... ...function a medical device design and... ...corporate objectives and regulatory requirements (QMSR, GMP... ...Build, mentor, and lead a high-performing quality...QualityRegulatoryMedical deviceHourly payWork experience placementFlexible hours
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