IVD Technical Documentation Reviewer Regulatory Focus
TUV SUD AMERICA, INC.
TUV SUD America is seeking a professional to perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements, focusing on ensuring compliance of IVD devices. Candidates need a degree in life sciences or a related field and several years of experience in areas including clinical evaluation and regulatory affairs. The position demands strong analytical skills and fluency in English as well as collaboration with multidisciplinary teams to prepare structured reports. Join us in fostering an inclusive workspace valued for diverse perspectives. #J-18808-Ljbffr TUV SUD AMERICA, INC.
- ...expert for TÜV SÜD, with focus on IVDR conformity assessment, CDx-specific regulatory strategy, and the interface between IVD devices and... ...products. Perform and guide Technical Documentation Assessments for CDx devices... ...including preparation and review of consultation...RegulatoryFlexible hours
- ...SUD Group. Tasks Perform Technical Documentation Assessments (TDA) in accordance... ...Assess compliance of IVD devices against applicable IVDR... ...Annex I, Annex IX, Annex X/XI) Review and evaluate: Performance... ...Performance (SSP) Assess specific regulatory requirements for Companion...Regulatory
$35 - $40 per hour
...meticulous and experienced Document Control Specialist to join our... ...change control system by reviewing, routing, assessing training... ...of education and experience. Technical Proficiency: Skilled in Microsoft... ...Part 820. Preferred Skills: Regulatory Knowledge: Ability to apply...RegulatoryFull timeTemporary workWork at office- Hydrogen Group is seeking a Technical Editor/Documentation Specialist in San Diego, California. This role involves researching, preparing, and editing... ...teams, ensuring adherence to editorial, customer, and regulatory standards. The ideal candidate has a Bachelor's degree in...RegulatoryContract work
- ...The Document Control Team is a key element of the Quality Assurance department and is responsible... ...quality records prior to scanning, reviews scanning packet information to ensure... ...Safety, Human Resources, and all other regulatory and administrative policies. Experience...RegulatoryContract workWork at office
$28 - $32 per hour
...Title: QA Specialist/Documentation Specialist Location: San Diego, California... ...formatting, coordinating the review and approval process,... ...Management System, with a specialty focus on document control and... ...documentation system. Experience with technical writing, formatting and...Work at officeShift work$45 - $50 per hour
Title: Technical Editor / Documentation Specialist - Utility Pay: $45.00-$50.00/hour Duration: 2- year contract... ..., and edit complex technical and regulatory documents in support of engineering,... ...Job Duties and Job Functions: Review, edit, and refine technical and regulatory...RegulatoryContract work$35 - $45 per hour
...to Hire position for aSenior Document Control Specialistto join a leading... ...maintenance, drawing package review, and configuration management... ...BOM information, and related technical records. Process and maintain... ...as assigned. Initial Focus / Expectations : Quickly learn...Contract workTemporary workFor contractorsWork at officeLocal areaImmediate start$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San Diego, US Contract... ...Full-Time Area: TECHNICAL Would you like to... ...complete, and accurate documents that are logically... ...regulatory risk. Review, provide... ...employees in 30 countries focused on patient health...RegulatoryFull timeContract workWork at officeLocal area$105.8k - $132.25k
...healthcare company is seeking a Regulatory Affairs Specialist III in San Diego, CA. This role focuses on ensuring regulatory... ...access for in-vitro diagnostic (IVD) products. Candidates must have... ...Affairs. Strong analytical and technical writing skills are essential. The...Regulatory- ...QC Reviewer A Few Words About Us Integrated Resources, Inc is a... ...appropriate analyses for successful regulatory submissions of oncology... ...modify submission-ready clinical documents by demonstrating high... ...apply new clinical data with a focus on the key messages is essential...Regulatory
$150k - $195k
...The Associate Director, Technical Operations, Biologics Drug... ..., Quality, and Regulatory Affairs on manufacturing... ...microbial fermentation, with a focus on downstream production... ...on downstream production.Review and approve manufacturing related documents including change...RegulatoryContract work$189k - $246k
Department:106800 Technical OperationsLocation:San Diego... ...We are a dedicated team focused on meeting the unique... ...closely with Quality, Regulatory Affairs, Clinical, and... ...manufactured at Travere CDMOs.Review and approve manufacturing-related documentation, including change...RegulatoryFull timeTemporary work- ...seeking an experienced Regulatory Affairs Manager to... ...in vitro diagnostic (IVD) medical devices in the... ...~ Lead preparation, review, and submission of FDA... ...and ensure submission documents are complete, consistent... ...Experience reviewing technical documentation, analytical...RegulatoryFull timeFlexible hours
$150k - $195k
Department:106800 Technical OperationsLocation:San Diego... ...are a dedicated team focused on meeting the unique... ...cGMP and international regulatory standards. The... ...at CDMOs/CROs.Author/review analytical method validation... ...product.Review controlled documents such as batch records...RegulatoryFull timeTemporary workRemote work- ...Akkodis is seeking a Document Control Specialist for a 6+ contract position in San Diego, CA. The role focuses on maintaining controlled documentation within the Quality Management System and supporting ECO processing, BOM maintenance, and document releases. The ideal...Hourly payContract work
- Artiva Biotherapeutics in San Diego is seeking a Quality Assurance Operations support professional focused on document control, records management, training management, and controlled labeling within Artiva’s eQMS. You will ensure accuracy, currency, traceability, and compliance...
- ...Includes a 30-minute lunch break Job Summary A leading national document management company is seeking 1-2 reliable Document Specialists... ...perfect for individuals who are detail-oriented and enjoy focused, independent work. This position features an interactive interview...Monday to FridayNight shiftAfternoon shift
- ...Technical Rules and Standards Associate San Diego... ...'s compliance with regulatory rules and standards... ...assessments and security reviews of compliance... ...preparing compliance documentation for regulatory filings... ...compliance-related training focused on technical rules,...RegulatoryContract workTemporary workWork at officeLocal area
$150k - $195k
...The Associate Director, Technical Operations - Drug Product... ...Operations, Quality, Regulatory CMC, Clinical, and Supply... ...product at company CDMOs. * Review and approve manufacturing related documents including change... ...product manufacturing with a focus on scale-up, late phase...RegulatoryWork experience placementRemote work$90k - $150k
...biotech organization focused on pushing the limits... ...motivated and experienced Regulatory Specialist to join our... ...strong background in IVD (In Vitro Diagnostics)... ...processes, including documentation, timelines, and communication... .... · Review and provide input on product...RegulatoryFull time$120k - $145k
...silencing.Arrowhead is focused on developing... ...This role will provide technical leadership for the strategy... ...Commercial, Quality, and Regulatory Affairs, to ensure... ...product use.Author and review human factors/usability... ...supporting design control documentation.Lead and support...Regulatory$85.91k - $162.89k
...a highly dynamic team focused on providing exceptional... ...sharpen your technical skills and build your... ...strategy and governance, IT regulatory and compliance requirements... ...business continuity. Review clients’ processes and... ...to the client, documenting and reviewing engagement...RegulatoryWork experience placementLocal area$150k - $195k
Department: 106800 Technical Operations Location: San Diego... ...are a dedicated team focused on meeting the unique... ...Operations, Quality, and Regulatory Affairs on... ...downstream production. Review and approve manufacturing related documents including change notifications...RegulatoryContract workTemporary workRemote work$85.91k - $162.89k
...a highly dynamic team focused on providing exceptional... ...sharpen your technical skills and build your... ...strategy and governance, IT regulatory and compliance requirements... ...business continuity Review clients' processes and... ...to the client, documenting and reviewing engagement...RegulatoryWork experience placementLocal areaWorldwide$55 per hour
...seeking a mid-senior level contractor for writing and editing. The role involves creating and maintaining technical documentation to meet regulatory requirements, focusing on user manuals and guides. Qualified candidates should have at least five years of experience in a...RegulatoryContract workFor contractors- ...multinational biotech organization is seeking a Regulatory & Compliance Specialist in San Diego. The role involves ensuring compliance with IVD product regulations, supporting product development, and managing documentation. Candidates should have a Bachelor's degree and...Regulatory
- Barrington James in San Diego seeks a Regulatory Affairs Specialist/Senior Specialist to lead complex global submissions (FDA,... ...with R&D, Quality, Clinical, and Engineering to assemble technical documentation, manage health authorities, and mentor junior staff while...Regulatory
$130k - $160k
...as a Senior Specialist 2, IT Technical Support & Maintenance, and... ...configurations and ensure proper documentation of changes.Integration... ...and participating in periodic reviews and audits.Work closely with... ...teams to ensure systems meet regulatory and operational requirements...RegulatoryFull time- Experis is seeking a QA Specialist/Documentation Specialist to join our Fortune 500 client in San Diego, onsite. The role focuses on document control, change orders, SOP drafting and training support within a regulated environment. Qualifications include a Bachelor's degree...Work at office
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