Quality & Regulatory Systems Specialist
Tenovi, an Inc. 5000 Company
Tenovi is hiring a Quality & Regulatory Specialist to manage the day-to-day quality system operations and keep FDA listings and device labeling compliant. This full-time individual contributor role collaborates with our regulatory advisor to roll out procedures, train staff, and maintain records in accordance with QMSR and ISO 13485. You will perform receiving inspection, handle nonconformances and CAPAs, manage document control, and support internal and FDA audits. #J-18808-Ljbffr
- Job-ID31853494Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...as a Medical Device preferred). Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21...Quality
- ...position is responsible for the preparation of regulatory submissions required to market medical... ..., including execution of procedures and systems designed to ensure that the product... ...specific registration information with R&D, Quality, Medical, Manufacturing, etc. Assess...QualityWork at office
$92k - $138k
...neurovascular conditions. The Regulatory Affairs organization partners across product development, quality, labeling, clinical, and... ...multiple products and regulatory systems across the Neurovascular portfolio... ...Senior Regulatory Affairs Specialist serves as a regulatory...QualityFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...Tenovi is hiring a Quality & Regulatory Specialist to run the day-to-day work of our quality system and keep our devices, labels and FDA listings compliant. This is a full-time individual contributor role. Our regulatory advisor designs and updates the quality system...QualityFull timeWork experience placementRemote work
$110.1k - $183.4k
...Flexibility: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this... ...needs and project efficiencies.Review quality, preclinical, clinical, and... ...and update internal monitoring and metric systems to drive optimization in regulatory submission...QualityFull timeFor contractorsLocal area$80k - $100k
...Regulatory Affairs SpecialistBring more to life.Are you ready to accelerate... ...And by harnessing Danaher's system of continuous improvement,... ....The Regulatory Affairs Specialist is responsible for obtaining... ...requirements for medical device.Quality Systems per ISO 13485.Graduate...QualityWork experience placementWorldwide$80k - $100k
...viewpoint matter. And by harnessing Danahers system of continuous improvement you help... ...makes everything possible. The Regulatory Affairs Specialist is responsible for obtaining... ...requirements for medical device. Quality Systems per ISO 13485. Graduate Degree...QualityFull timeWork experience placementWorldwide- Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver... ...design control deliverables. Prepare Quality Assurance/Regulatory reports and... ...with requirements of 21 CFR Quality System Regulations/cGMPs and ISO 13485 Quality...QualityImmediate start
- ...Regulatory SpecialistThe Regulatory Specialist supports regulatory compliance, accreditation, authorization, and licensure... ...compliance, supports continuous quality improvement initiatives, and... ...Maintain compliance calendars, tracking systems, and documentation repositories to...QualityWork at office
- ...Senior Regulatory Affairs SpecialistWork mode: Hybrid Onsite Location... ..., we continually advance the quality of patient care with innovative... ...a Senior Regulatory Affairs Specialist position (hybrid work mode)... ..., design control and quality system regulationsAbility to simultaneously...QualityWork at officeLocal areaRelocation3 days per week
- ...Principal Regulatory Affairs SpecialistDiality is a medical device company... ...the Moda-flx Hemodialysis System, a user-friendly, mobile, and... ...Principal Regulatory Affairs Specialist will serve as a key... ..., consistently delivers high-quality work products, and drives activities...QualityWork at office
$55 - $60 per hour
Take your regulatory affairs expertise to the next level with an opportunity to support... ...Matters As a Regulatory Affairs Specialist III, you will help ensure critical diagnostic... ...writing skills Experience using quality management systems and SAP applications Ability to...QualityHourly payTemporary workMonday to Friday- The Kardion Regulatory Affairs team is seeking a high energy, driven... ...Principal Regulatory Affairs Specialist is a senior technical expert... ...synthesizes information across complex systems, and builds regulatory... ...teams including R&D, Quality, Clinical, and Marketing, providing...QualityFull timeContract workRemote work3 days per week
- ...OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Quality Systems Complaints Specialist. The Quality Systems Complaints Specialist determines the legitimacy of complaint feedback and processes complaint files. This role...QualityLocal areaImmediate start
- ...Parker Hannifin is seeking a senior quality leader to oversee the quality function at the facility, ensuring compliance with company... ...and maintaining supplier quality programs, audits, and corrective actions, using automated systems to monitor quality #J-18808-Ljbffr...Quality
$100k - $145k
...Job Description Job Description The Quality Systems Manager ensures the Quality Management System (QMS) remains compliant, effective... ...resolve quality system issues, and support external audits and regulatory inspections. This role requires strong leadership, project...QualityFull timeLocal areaMonday to FridayFlexible hoursAfternoon shift$85.8k - $137.3k
...industry and a strong concern for quality and accuracy of work with a... ...in various ERP systems or tools.Continuously monitor... ...and SKU lists for Compliance Specialists and ManagementReview and upload... ...SupervisorAdministrative support for required regulatory reporting requirements in a...QualityFull timeTemporary workImmediate startWorldwideFlexible hours$91.7k - $163.7k
...StatesSalary: $91,700 - $163,700/yearJob Area: Regulatory & ComplianceCompany: UnitedHealth... ...partners closely with Utilization Management, Quality Management, Network Management, Customer... ...lives and help make the health system work better for everyone. Together, we are...QualityMinimum wageFull timeWork experience placementWork at officeLocal areaRemote work- Anduril Industries, a leader in defense technology, seeks a Quality Manager to lead a team of quality engineers and specialists in delivering high-quality, reliable products for Intelligence Systems. You will partner with production, manufacturing engineering, program...Quality
- ...Facebook, Instagram, X and YouTube. Job Description Quality Systems and Compliance Manager with knowledge of quality systems management... ...Responsibilities: Oversee and manage all aspects of regulatory, quality, and corporate audits, and track resulting action...QualityLocal area
- ...e.g., SOC 2 Type II reports, high level system architecture diagrams, information security... ...and as part of a team to deliver quality workAttention to detail, and the ability... ...institution experienceUnderstanding of higher education legal and regulatory environment...QualityRemote work
$150k - $165k
.... Base pay range $150,000.00/yr - $165,000.00/yr The Senior Quality Systems Manager will oversee all aspects of the company's Quality Systems... ...Lead and manage Quality Systems, ensuring compliance with regulatory and ISO requirements. Oversee internal and external audits,...QualityFull timeLocal area$146k - $194k
...industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family... ...requirements. About The Job As the Quality Manager you will lead a team of product quality engineers and quality specialists who will work inside & outside the organization...QualityFull timeWork experience placementRemote work- ...Job Description Job Description Description: Quality Management System (QMS) Develop, implement, and maintain the company QMS in alignment... ...action requests (SCARs) and containment activities. Regulatory & Safety Compliance Support compliance with applicable...Quality
$80k - $95k
The Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities... ...and shipping authorizations to Quality Assurance and other appropriate functions... ...policies, procedures, quality system requirements, and applicable business...QualityWork at officeWorldwideWeekend workAfternoon shift$23 - $25 per hour
...Coordinator (HOA Compliance Specialist) will be responsible for assisting... ...level of client services, quality assurance and best practice... ...Residential’s internal software systems (e.g. Connect, Jenark,... ...compliance. Stay Abreast of Regulatory Changes Civil Code and laws...QualityFull timePart timeWork at officeLocal areaMonday to FridayFlexible hoursWeekend workAfternoon shift$80k - $100k
...Regulatory Affairs Specialist at Masimo, a Danaher medical technology company, manages domestic and international regulatory clearances for medical... ...knowledge preferred ~ FDA/GMP and ISO 13485 quality systems knowledge preferred ~ Graduate degree preferred Compensation...QualityWorldwide$92k - $138k
...Senior Regulatory Affairs Specialist supporting Medtronic's Neurovascular business in Irvine, California... ...and business processes Manage data quality reviews, discrepancy resolution,... ...stakeholder coordination Support regulatory systems implementation, testing, validation,...Quality- ...Senior manager responsible for overseeing quality systems, regulatory compliance, and supplier quality at a pharmaceutical manufacturing site. Ensures adherence to GMP requirements, maintains inspection readiness, and drives continuous improvement in quality and training...Quality
- ...Terran Orbital is seeking an experienced Manager, Test Systems to lead a dedicated test engineering team responsible for spacecraft module, subsystem, and full-vehicle testing. You will oversee test systems development, automated test tools, environmental test readiness...
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