Senior Medical Device Complaints & MDR Specialist
$75k - $100kHeartFlow, Inc
HeartFlow, Inc in Austin, Texas is seeking a Senior Complaint Specialist responsible for managing product complaints and ensuring compliance with regulatory standards. The role requires experience in the medical device industry with an emphasis on complaint handling and regulatory reporting. Ideal candidates will possess 5+ years of relevant experience and a Bachelor's degree in a related field. This position offers a salary range of $75,000 to $100,000 plus bonuses. #J-18808-Ljbffr HeartFlow, Inc
- Heartflow is a medical technology company advancing the diagnosis and management... ...worldwide. The Opportunity As our Senior Complaint Specialist, you will play a critical role in... ...Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external...SeniorComplaintsMedical deviceWork experience placementLocal areaWorldwideRelocation
$75k - $100k
Heartflowinc is hiring for a Senior Complaint Specialist to oversee product complaint management and ensure compliance with global regulations... ...efforts. Candidates should have at least 5 years in the medical device industry and possess strong regulatory knowledge. The...SeniorComplaintsMedical device- Heartflow is seeking a Senior Complaint Specialist in Austin, Texas. You will ensure the safety and regulatory integrity of our products through... ...field and at least 5 years of experience in the medical device industry. Knowledge of regulatory standards and excellent...SeniorComplaintsMedical device
- Confluent Medical Technologiesis dedicated to working... ...deliver world-class medical devices through innovative... ...for a Quality Engineer, Senior Staff to join our Austin... ...manage customer field complaints, SCAR’s and internal CAPA... ...FDA, ISO 13485 and EU MDR Design Control...SeniorComplaintsMedical deviceWork at officeLocal areaVisa sponsorshipWork visa
$86.7k - $173.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...executives, and scientists.The Opportunity The Senior Manager, Global Market and Competitive... ...or irregular heartbeats.As the Senior Specialist Pricing will be responsible for...SeniorMedical device$140.47k - $190.04k
...while transforming your career.Senior Oncology SpecialistWhat you... ...knowledge of our products to medical professionals. Amgen's medicines... ...for a Senior Oncology Specialist to deliver on this commitment... ...biotech, healthcare, or medical device industries. Product or hospital...SeniorMedical deviceFull timeLocal areaRemote workRelocationFlexible hours$78k - $156k
...with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,0... ...female executives, and scientists.The Opportunity The Senior Marketing Project Specialist, Direct-to-Consumer (DTC) & Marketing Communications (...SeniorMedical device$163.4k - $322.1k
...capability for Life Sciences clients. This Senior Manager role sits at the intersection... ...and procurement for biopharmaceutical, medical device, and broader life sciences... ...management, master data management, or product complaint triage and initial investigationAbility...SeniorComplaintsMedical deviceStart working todayLocal areaFlexible hoursShift work$129.3k - $258.7k
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000... ...Systems include Nonconformance and CAPA Change control Complaints Batch release Label development and control Related budget...SeniorComplaintsMedical deviceWorldwide- ...upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745, ensuring audit readiness, risk-... ..., Sterilization, Validation) CAPA, Complaint Handling, and Post-Market Surveillance (PMS...ComplaintsMedical deviceImmediate start
- ...quality-compliant outcomes. Interpret and apply medical device regulations and standards to projects and... ...strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR. Hands-on experience in: Quality Management Systems (QMS) Complaint Management Post Market Surveillance (PMS) Non...ComplaintsMedical deviceRemote work
- ...and product changes for RMF impact. Monitor post-market data (complaints, CAPAs, NCRs, customer feedback). Provide investigation... ...in an FDA-regulated industry (pharmaceutical, biomedical, or medical device), with strong knowledge of GMPs, QSR, and ISO standards main...SeniorComplaintsMedical deviceWork experience placementRemote work
- ...****@*****.*** length: 8/24 - 12/31A medical device company in Texas is seeking a contractor to provide product life... ...and complete regulatory impact assessments * Support PMA, MDR, and MDD file maintenance for high risk products * Ensure compliance...SeniorMedical deviceFor contractors
- ...ENOV) is an innovation-driven medical technology growth company... ...ResponsibilitiesServe as the senior Quality Assurance representative... ...teams.Evaluate quality metrics, complaint trends, nonconforming... ...experience within the medical device industry or another highly regulated...SeniorComplaintsMedical deviceFull timeH1bWork at office
- ...requirements, consistent with federal, state, and local laws. Supporting medical or religious documentation will be required where applicable... ..., unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding,...SeniorComplaintsFor contractorsWork at officeLocal areaRelocation
- ...lifecycle.Key ResponsibilitiesServe as the senior Quality Assurance representative for... ...teams.Evaluate quality metrics, complaint trends, nonconforming material, and manufacturing... ...Assurance experience within the medical device industry or another highly regulated industry...SeniorComplaintsMedical deviceFull timeH1bWork at office
- ...contractor in Texas to provide lifecycle support for a Class III medical device during a medical leave. The role involves strategic regulatory... ...requirements. The candidate will contribute to PMA, MDR, and MDD file maintenance, ensure ongoing compliance, and collaborate...SeniorMedical deviceContract workFor contractors
- ...is an innovation-driven medical technology growth... ...patient outcomes.Job Title: Senior Regulatory Affairs SpecialistLocation... ...an experienced medical devices regulatory affairs... ...as the Senior RA Specialist. This role will develop... ...(TGA) regulations, EU MDR ISO 13485, ISO 14971, 2...SeniorMedical deviceFull timeH1bWork at officeLocal area
- ...Senior Biomedical TechnicianWe are searching for a Senior Biomedical Technician for our Austin, TX Campus -- someone... ...preventative maintenance and repair work on a wide variety of medical equipment, some complex devices, systems, and networks. Think you've got what it takes?...SeniorMedical device
- ...ENOV) is an innovation-driven medical technology growth company... ...patient outcomes.**Job Title:** Senior Product Development Engineer*... ...instruments and implants medical devices used in Total Shoulder... ...respond to common inquiries or complaints from customers, regulatory agencies...SeniorComplaintsMedical deviceFull timeInternshipH1bWork at officeLocal area
- Innolitics seeks a Medical Device Software Engineer to drive both software development and regulatory design assurance for medical device projects. The role spans writing code, performing cybersecurity work, and creating FDA-aligned documentation. You will collaborate...SeniorMedical device
- ...with the goal of transforming medical technology as we know it.... ...patient outcomes. Job Title: Senior Product Development Engineer... ...instruments and implants medical devices used in Hip Arthroplasty. Key... ...respond to common inquiries or complaints from customers, regulatory...SeniorComplaintsMedical deviceFull timeContract workInternshipWork at officeLocal area
- Innolitics is a remote-first company specializing in medical device software development and FDA regulatory consulting. We work across software engineering and regulatory compliance to deliver robust, traceable systems. As a Medical Device Software Engineer, you will engage...SeniorMedical deviceRemote job
- A leading medical technology company in Austin, TX is seeking a Senior Product Development Engineer to participate in the design and development of surgical instruments... ...Engineering, and experience in the medical device industry is preferred. The position involves collaboration...SeniorMedical device
- ...teams across the organization. The ideal candidate will have a J.D. and significant experience in privacy law, especially within medical devices or high-growth health tech environments. A competitive compensation package, including equity, is on offer. #J-18808-Ljbffr...SeniorMedical device
- Job-ID32840712Reference26-01429 Job Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation... ...environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS,...SeniorMedical device
- Varian Medical Systems, a Siemens Healthineers company, seeks a Sr Product Quality Engineer on-site in Austin. You will lead quality assurance... ...Six Sigma/Lean methodologies and risk-based problem solving in a fast-paced medical device #J-18808-Ljbffr Siemens Healthineers inSeniorMedical deviceLocal area
- Enovis Corp in Austin, Texas is looking for a CNC Machine Programming Supervisor to lead CNC programming activities. In this role, you will oversee programming functions and collaborate with teams to ensure efficient operations in orthopedic implant production. The ideal...SeniorMedical device
- ...provider consulting environmentInterest in procurement topics (medical/surgical supplies, pharmacy, purchased services), clinical operations... ...to backgrounds working for GPOs, pharmacy companies, medical device companies and/or healthcare consultanciesDeep interest and...Medical deviceApprenticeshipEasy work
- ...experience in Microsoft Dynamics 365 Business Central, particularly with a proven track record in the medical device manufacturing sector. Ideal candidates should hold mid-to-senior level positions, showcasing strong supply chain architecture skills and client-facing advisory...SeniorMedical device
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