Senior CDx Specialist - IVDR & Regulatory Strategy
TÜV SÜD
TÜV SÜD Gruppe sucht eine/n erfahrene/n Senior Companion Diagnostics Experte/in. Hauptfokus liegt auf IVDR‑Konformität, CDx‑spezifischer Regulierungsstrategie und der Schnittstelle zwischen IVD‑Geräten und Arzneimitteln. Sie führen Technical Documentation Assessments durch und steuern die Evidenzpakete. Sie arbeiten eng mit klinischen, regulatorischen, QMS-, Software‑, Biomarker‑Fachbereichen zusammen und vertreten das Unternehmen extern in Gremien und bei Fachveranstaltungen. #J-18808-Ljbffr TÜV SÜD
$103.3k - $141k
...Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment... ...and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trials...SeniorRegulatoryLocal area$42 per week
...Description Job Title: Senior EHS Specialist Location: San Diego, CA Employment: Contract (12 months)... ...environment. In this role, you'll lead training strategy, strengthen leadership engagement, ensure regulatory compliance, and help build a proactive safety...SeniorRegulatoryContract workWorldwide- ...biopharmaceutical company based in San Diego is seeking a Senior Director/Director of AOC Analytical... ...Control. This role will lead analytical strategy and quality control activities, manage teams, and ensure compliance with regulatory requirements. Ideal candidates should...SeniorRegulatory
- Ascendiun seeks a Senior Director, Tax Accounting to lead enterprise tax strategy, compliance, and specialty accounting across the family of companies. You will ensure accurate execution, regulatory compliance, and disciplined risk management, reporting to the VP Controller...SeniorRegulatory
- ...customer insights into innovative diagnostic solutions. You will influence product strategy from concept through launch readiness, collaborating with R&D, Clinical Affairs, Regulatory, Operations, and Commercial teams to shape the next generation of diagnostic products...SeniorRegulatory
- Pattern Energy seeks an experienced Manager, Environmental Compliance & Strategy, EPC to lead regulatory and environmental permit compliance for wind, transmission, and solar projects in the United States and Canada. The role collaborates with internal teams, consultants...SeniorRegulatoryLocal area
- ...strategic and scientific leadership for clinical programs, set the strategy for approved products, and oversee trials in all stages. You... ...guide design, plan and execution of clinical studies, ensure regulatory compliance, and partner with leadership on development...SeniorRegulatory
- ResMed Inc in San Diego, CA seeks a Senior Manager, Commercial Services - Diagnostics to... ...service programs, aligning product strategy, service design, and operations to drive... ...deliver measurable results while ensuring regulatory compliance. #J-18808-Ljbffr ResMed IncSeniorRegulatory
$130k - $160k
...mission and making our One Team culture thrive.Join us as a Senior Specialist 2, IT Technical Support & Maintenance, and you’ll be part of... ...internal audit, QA, and compliance teams to ensure systems meet regulatory and operational requirements.User Training &...SeniorRegulatoryFull time- Mission Federal Credit Union in San Diego, CA is seeking a Senior Consumer Loan Officer to evaluate loan applications across auto loans... .... This on-site position emphasizes sound lending decisions, regulatory compliance, and delivering exceptional member service in a fast...SeniorRegulatory
$85k - $100k
...Senior Compensation SpecialistThe Senior Compensation Specialist is responsible for managing the collection and analysis of external compensation market data, shaping... ...and local legislation, and other government and regulatory requirements.What you will have:Minimum 3-years...SeniorRegulatoryWork experience placementWork at officeLocal area$235k - $285k
...inform commercial planning and pre-launch strategy. Conducts market assets and development... ...present strategic recommendations to senior leadership and the Board. Develop and own... ...teams (early research, bioinformatics, regulatory, clinical, quality, business development...SeniorRegulatoryFull timeWork experience placement- ## Sr. Specialist CLS - Copley Lab - Day Shift - Full TimeApplylocations: San Diego, CAtime... ...performs technical lead duties. Apprises Senior Specialists, Lab Managers or... ...AABB, FDA, and other accreditation and regulatory agency standards and regulations. Demonstrates...SeniorRegulatoryHourly payFull timeShift workWeekend workDay shift
$80k - $90k
...Job Shift: DayJob Category: Supply Chain Job Summary The Senior Global Trade Specialist will oversee and optimize our Maquiladora/IMMEX operations... ...processes, customs compliance, and inventory control. Regulatory Compliance: Ensure compliance with all relevant international...SeniorRegulatoryRemote workShift work- The National City Chamber of Commerce NCCC in San Diego is seeking a Senior Counsel - Regulatory to advise on complex legal matters and manage regulatory compliance. In this role, you will represent SDG&E in various proceedings while developing innovative solutions that...SeniorRegulatory
$1,000 per month
...entire organization. Position Summary Trulioo is seeking a Senior Director of Corporate Strategy & Development to help shape the company’s strategic... ...Senior Director will bring together customer, competitive, regulatory, economic, industry, and product insights to test...SeniorRegulatoryPermanent employmentFull timeWork at officeLocal areaWorldwideFlexible hoursShift work3 days per week- Uniquity Design Group is seeking a Senior Director, Head of Statistical Programming to lead and enhance our statistical programming function... ...teams to ensure the highest quality of statistical outputs for regulatory submissions. Candidates must have significant experience within...SeniorRegulatory
- ...nursing staff development in response to patient and healthcare trends, regulatory requirements, and organizational strategic priorities. Uses appropriate teaching/learning principles and strategies and current information, standards, and technologies to facilitate...SeniorRegulatoryHourly payFull timeShift work
- EP Wealth Advisors seeks a Senior Financial Planner to work with advisors in the San Diego region, developing and delivering tailored... ...mentor junior planners while staying current on market trends and regulatory changes to keep services competitive. #J-18808-Ljbffr EP...SeniorRegulatory
- ...cross‑functional teams. The candidate will contribute to protocol design, SAP development, and statistical deliverables, with strong SAS programming and regulatory familiarity. A PhD or MS with extensive biotech experience is preferred. #J-18808-Ljbffr FatetherapeuticsSeniorRegulatory
- ...design, analysis, and reporting of trial data. You will design and analyze statistical deliverables, support EDC and study setup, and collaborate with cross-functional teams to ensure regulatory compliance and high-quality results. #J-18808-Ljbffr Fate Therapeutics Inc.SeniorRegulatoryFull time
- Elion Therapeutics is seeking a Senior Director, Clinical Data Management to lead data governance, quality, and strategic CDM initiatives... ...position emphasizes building robust data governance, ensuring regulatory readiness, and guiding teams through complex data management...SeniorRegulatory
- Protego Biopharma is seeking a Senior Director, Regulatory Affairs (CMC) to lead the global CMC regulatory strategy for a first-in-class small molecule program advancing toward NDA/MAA submission. The role combines strategy, authoring, and hands-on submissions, reporting...SeniorRegulatory
- ...Senior Counsel - Regulatory Primary Purpose Advises on complex legal issues and develops practical solutions that balance risk management with... ...penalties and reputational damage. Oversees and develops legal strategies and coordinates with external counsel to resolve disputes...SeniorRegulatory
- Circle is seeking a Senior Manager to join the Regulatory Assurance team to build a central global function for a best-in-class compliance management... ...changes across jurisdictions. You will drive strategy, oversight, and reporting for the program, while supporting...SeniorRegulatory
$245k - $420k
...generator interconnection policies, and market participation.FERC regulatory: represent clients in high-stakes proceedings before the... ...renewable energy integration, and carbon-free energy procurement strategies.Practice development: with partners in EER, actively...SeniorRegulatoryFull timeWork at office$166.38k - $189.53k
...ensuring that drug substance manufacturing processes meet quality, regulatory, safety, scalability, and scalability expectations. Position... ...development organization, designing and executing synthetic strategies that enable discovery programs. The successful candidate will...SeniorRegulatory- ...cell therapies to restore immune balance. The Senior Director, Quality (SD) oversees the quality organization, shaping strategy, implementing systems, and driving... ...internal and external stakeholders to meet regulatory requirements and business goals. #J-18808-Ljbffr...SeniorRegulatory
$150k
...highly successful organization, is seeking a Senior Tax Analyst to join its corporate tax... ...of tax positions .Analyze legislative and regulatory tax developments and assess their potential impact on the organization’s tax strategy and reporting requirements .Conduct...SeniorRegulatoryLocal area- CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle. You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant...SeniorRegulatory
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