17 Jobs für Clinical Compliance Auditor
Stellenangebote Clinical Compliance Auditor Jobs
Job am 20.01.2026 bei Jooble gefunden
SGS
• Meinerzhagen
Führungs-/ Leitungspositionen
[. .. ] of Role Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639. This role ensures the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management. Oversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives. The role reports to the Head of Notified Body 1639. Key Accountabilities The role encompasses a wide range of responsibilities, including but not limited to [. .. ] QMS requirements. Excellent interpersonal and stakeholder management skills. Strong organizational and change management capabilities. Strong commercial understanding and appreciation of the TIC industry. Experience in resource planning. Qualification as Lead Auditor or Product Assessor under EU MDR/ EU IVDR. Qualification as Final Reviewer and Decision Maker under MDR or IVDR. Experience in a Notified Body or equivalent regulatory organization. Experience Essential Minimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment. [. .. ]
Job am 14.01.2026 bei Jooble gefunden
Merz Therapeutics
• Frankfurt am Main
Work-Life-Balance
[. .. ] f/d) , you will be responsible for quality assurance within the R D departments at Merz Therapeutics, in accordance with applicable regulations-including requirements for IT systems used [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] in clinical trials. This is a full-time position, and your key responsibilities will include: Development and maintenance of systems and tools supporting quality processes Quality management in accordance with GCP and IT regulations (e. g. , GAMP, 21 CFR Part 11) Planning and execution of audits, including reporting and CAPA follow-up Support with quality-related and IT-specific inquiries Ensuring compliance in global clinical development projects Preparation for and support during regulatory inspections Delivery of GCP training sessions as needed YOUR PROFILE Completed scientific degree or equivalent training Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance Sound knowledge of GCP requirements for the clinical development of drugs Good knowledge of MS Office, quality management processes Excellent communication skills, ability to work in a team, and a structured approach to work High level of responsibility, Strong team spirit and interest in [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• München, Bayern
[. .. ] belonging where your unique viewpoint matters. By harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, [. .. ] collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. Responsibilities Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews; Ensure compliance with the European Medical Device Directive and associated regulations; Liaise with the regional and global Quality Regulatory Affair organization to support the development of and ensure alignment with BEC global policies and procedures; Establishing and developing commodity requirements; Leads key supplier sourcing and qualifications processes. Job Requirements Minimum of 5 [. .. ] Six Sigma, Problem Solving, Statistical Tools) Knowledge of EU, FDA and related regulations including QSRs, (FDA 21 CFR 820) , ISO 13485, ISO 9001 and the EU IVDD Certified internal auditor ISO 9001 or ISO 13485 Experienced in working within multi-functional, multi-regional teams Fluent in German and English languages. Good computer skills which include Microsoft Applications, Databases and Web-based Tools. Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
• Rüti (ZH) , Zürich Rüti (ZH)
Führungs-/ Leitungspositionen
Overview As one of the fastest-growing providers of in-home healthcare, we combine world-class
clinical standards with operational excellence and modern technology. Families trust us because we respond quickly, advocate for [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] caregivers, and operate with integrity and reliability. We believe people receiving care at home deserve dignified, self-determined lives and that caregivers are heroes whose work must be supported and fairly compensated. Our mission [. .. ] results faster each cycle. Eliminate manual bottlenecks through intelligent workflows and intercompany automation. Establish and continuously strengthen a robust internal control framework aligned with PCAOB-level expectations. Technical Accounting Regulatory Compliance : Interpret and apply accounting standards to new business models and transactions with speed and precision. Ensure full compliance with Swiss statutory requirements (OR accounting, tax, VAT, regulatory filings) while optimizing for efficiency. Manage annual audits through flawless preparation, proactive auditor management, and data-driven documentation. Provide authoritative technical guidance on revenue recognition, leases, capitalization, cross-border matters, and group reporting topics. Team Leadership Capability Building : Build and lead a high-performing team of 10+ accounting professionals, attracting and developing top talent. Create a culture of ownership, analytical rigor, and [. .. ]
Job am 24.01.2026 bei Jobleads gefunden
[. .. ] delivering high-quality, person-centred services across multiple disciplines in Southern Adelaide. We are seeking an experienced General Manager/ Operational Manager with strong expertise in NDIS Practice Standards, auditing, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and compliance governance to lead the organisation into its next phase of growth and operational maturity. This is a senior executive role with accountability for operations, financial sustainability, compliance, and high-quality service delivery in complex and high intensity NDIS environments. This role provides the opportunity for a leader who can balance [. .. ] Lead, mentor, and inspire multi-disciplinary teams across multiple sites. Develop senior leaders and managers to strengthen capability, performance, and succession planning. Ensure compliance with worker screening, training, supervision, and clinical governance requirements Foster a high performing, inclusive, and values aligned workplace culture. NDIS Compliance Sector Expertise Ensure full compliance with NDIS Practice Standards, restrictive practices requirements, and relevant legislation. Lead and manage preparation for NDIS certification and surveillance audits, including auditor engagement and corrective action planning Maintain operational readiness for audits and high-intensity service delivery. Proactively address sector specific challenges with practical, risk aware solutions. Operational Excellence Systems Oversee systems, processes, and workflows to ensure efficiency, scalability, and quality outcomes. Implement and monitor quality assurance, continuous improvement, and risk management [. .. ]
Job am 23.01.2026 bei Jobleads gefunden
• Wien
[. .. ] edge AI-powered data analysis Services, that make it possible to standardize the process of skin imaging, objectify disease and treatment assessment, and to accelerate data collection and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] analysis in clinical trials and medical routine. We are growing and seeking new, experienced and hands-on team members who think outside of the box, deliver unique ideas and like to work in a fast-paced digital health and medical research environment. You are reliable, ambitious, your heart beats for clinical trials, digital [. .. ] risk management plan, FMEA, hazard analysis, risk management report) and quality planning activities for assigned projects. Responsible to ensure that assigned medical device and combination product development projects are in compliance to IEC 62304, MDR, ISO 13485, ISO 14971, and other relevant global regulations and international standards. Provides DQ technical quality support for regulatory filings in EU, USA and Japan Provides DQ technical support including planning, execution, and reporting of design verification and validation activities for Sa MD. Leads quality improvement initiatives [. .. ] development and regulatory filings Experience working with external manufacturing partners Desired Advanced Degree and Experience working in Pharmaceutical/ Biotech/ Device industry, Software Application Medical Device Engineering background preferred, Quality IT; Auditor certification. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team. Strong decision-making skills even in times of uncertainty. Responsible for continuous improvement on an ongoing basis to [. .. ]
Job am 23.01.2026 bei Jobleads gefunden
Global Head of Delivery and Operations
• Meinerzhagen, Nordrhein- Westfalen
Führungs-/ Leitungspositionen
[. .. ] of Role Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639. This role ensures the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management. Oversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives. The role reports to the Head of Notified Body 1639. Key Accountabilities The role encompasses a wide range of responsibilities, including but not limited to [. .. ] QMS requirements. Excellent interpersonal and stakeholder management skills. Strong organizational and change management capabilities. Strong commercial understanding and appreciation of the TIC industry. Experience in resource planning. Qualification as Lead Auditor or Product Assessor under EU MDR/ EU IVDR. Qualification as Final Reviewer and Decision Maker under MDR or IVDR. Experience in a Notified Body or equivalent regulatory organization. Experience Essential Minimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment. [. .. ]
Job am 22.01.2026 bei Jobleads gefunden
• Berlin
[. .. ] in healthcareto date with 500, 000 participating women. Our mission is to make breast cancer screening more effective, measurable, and accessible. By enhancing early detection and ensuring [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] outcomes backed by clinical evidence, were proud to contribute to national efforts focused on improving womens health. Founded in 2018 as the first company to emerge from Europes leading AI venture studio, Merantix, Vara has grown into an international team of 25 driven professionals. Our diverse team brings together entrepreneurs, healthcare experts, and technology [. .. ] be found on our website: Your role As Quality Manager in Regulatory Affairs, you will be responsible for maintaining and continuously improving the companys Quality Management System (QMS) , ensuring compliance with ISO 13485 and applicable regulatory requirements. You will coordinate updates to key SOPs and processes, support internal audits, data privacy, and IT security, and act as the person responsible for regulatory compliance in accordance with MDR. You will also provide guidance and support to employees and stakeholders on quality [. .. ] ISO 14971) Familiarity with AI/ ML validation, software development workflows, and lifecycle management Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA Sa MD Guidance, IMDRF) Nice to have: Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 as a plus) Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001) Understanding of AI/ ML-specific regulatory requirements (e. g. , GMLP, EU AI Act) Prior experience in startup or scale-up environments Fluent in German (minimum B2-level) [. .. ]
Job am 13.01.2026 bei Jobleads gefunden
• München, Bayern
[. .. ] and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour [. .. ] quality assurance activities for the manufacturing of our automate instruments at our Munich Location. Responsibilities Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews; Ensure compliance with the European Medical Device Directive and associated regulations; Liaise with the regional and global Quality Regulatory Affair organization to support the development of and ensure alignment with BEC global policies and procedures. Establishing and developing commodity requirements. Leads key supplier sourcing and qualifications processes. Qualifications Minimum of 5 years [. .. ] Six Sigma, Problem Solving, Statistical Tools) Knowledge of EU, FDA and related regulations including QSRs, (FDA 21 CFR 820) , ISO 13485, ISO 9001 and the EU IVDD Certified internal auditor ISO 9001or ISO 13485. . Experienced in working within multi-functional, multi-regional teams Fluent in German and English languages. Good computer skills which includes Microsoft Applications, Databases and Web-based Tools. Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We [. .. ]
Job am 21.12.2025 bei Jobleads gefunden
• Stuttgart, Baden- Württemberg
Beratungs-/ Consultingtätigkeiten
[. .. ] support a wide variety of clients in the medical device industry. Leveraging your regulatory expertise, you will help Qserves clients achieve their business goals by providing handson [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] support, ensuring regulatory compliance, and enabling market access for a broad range of medical devices. You will be part of a global team of medical device experts, working collaboratively across regions and time zones to deliver highquality support to our clients. What Youll Bring To The Team We are looking for a highly motivated [. .. ] At least 7 years of professional experience in the medical device field (EU MDD and EU MDR) , gained in industry, consultancy, or a Notified Body, in quality, regulatory, or clinical roles. Solid knowledge of quality assurance and regulatory affairs within the Med Tech industry or a Notified Body environment. Qualified to perform ISO 13485 and MDSAP audits as a lead auditor. Indepth knowledge of EU Medical Device Regulations (EU MDR) and US regulations. Familiarity with medical device risk management. Handson experience in writing technical and regulatory documentation. Experience in implementing and managing medical device quality management systems (ISO 13485) . Practical knowledge of project management. Pragmatic mindset, enjoying a mix of [. .. ]
Job am 15.12.2025 bei Jobleads gefunden
Principal Quality Engineer
[. .. ] In The Life The Principal Quality Engineer is responsible for building, overseeing and implementing all relevant processes and procedures within the specific country/ territory (OUS) to ensure [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] the quality and compliance of all products and activities released by the Company. Responsible for the development and implementation of quality plans that will result in short and long-term sustainable growth of the countrys specific business. Responsibilities include support to all supply chain activities, clinical team activities, marketing, commercial, GPMS, customer care, suppliers qualification, evaluation and monitoring. In addition, supports all activities related to NCs and CAPAs related to OUS activities. The Principal Quality Engineer will interact with the department staff to determine quality system requirements and provide quality support to drive the continuous assessment [. .. ] Experience with International Relations, preferred. Experience with distributors and importers, preferred. Extra Awesome Bachelors degree in engineering, preferably Mechanical Engineering or the equivalent education and applicable work experience. ISO lead auditor certification or equivalent, preferred. 10 years of related experience in the field including: Experience leading and partnering with a quality assurance team through the various stages of development, from small startup organization to large organization. Experience supporting US and international regulatory authorities or notified bodies. Experience conducting internal audits. Why [. .. ]
Job am 20.11.2025 bei Jobleads gefunden
Senior Auditor Quality Assurance Manager (m/f/x)
• Baden- Württemberg
Jobticket
Senior QA
Auditor (m/f/d)
Clinical Trials Responsibilities: Lead audits for clinical trials and medical products to ensure
compliance with Gx P and regulatory standards. Develop and implement [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] audit plans based on risk assessments and conduct internal process and vendor audits. Address and escalate serious clinical trial violations, ensuring timely resolution. Contribute to the development and maintenance of the Quality Management System (QMS) , focusing on document management, CAPA, deviations, [. .. ]
Job am 23.10.2025 bei Jobleads gefunden
QA Manager Medical Device Development (m/f/d) , R D Quality
• Frankfurt, Hesse
[. .. ] and maintaining the skins beauty. Would you like to become part of our success story? Then join Merz Aesthetics You lead R D project teams through Design [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Control requirements, ensuring compliance across development phases, supporting preclinical and clinical planning, contributing to regulatory submissions, and facilitating smooth transfer to manufacturing. You manage risk and usability processes, guiding activities, documentation, and cross-functional input throughout all stages of the product development lifecycle, including maintaining the risk management plan, risk file, and usability strategies. You support audits and inspections, preparing for [. .. ] are experienced in ensuring quality compliance throughout design and manufacturing processes. You ideally hold or are pursuing certifications such as ASQ Certified Quality Manager, Certified Quality Engineer, or Certified Quality Auditor. You are proficient in both electronic Quality Management Systems (e. g. , Master Control, SAP, Oracle) and MS Office applications, supporting effective documentation and communication. You demonstrate strong organizational and communication skills, with the ability to manage priorities independently, maintain attention to detail, and clearly convey technical concepts across functions [. .. ]
Job am 01.10.2025 bei Jobleads gefunden
Regulatory Technical Reviewer (m/f/d) - Healthcare
• Plattling, Bayern
[. .. ] for people like you to help make it happen. Responsibilities To ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] respect to product clinical performance including alignment with state-of-the-art expectations and defended risk/ benefit for the product. To formulate, maintain and improve assessment procedures and protocols in line with both CSA Group and external Authority expectations. Independently manages certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines. Evaluates products against requirements of the national/ international standards and precedent decisions. To support the Commercial team in the formulation and effort estimation for the clinical assessments of product on an as needed basis. Delivers assigned projects [. .. ] UKCA, FDA) . Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under regulatory conformity assessment procedures. Qualification as management system auditor in the healthcare sector. Strong interpersonal skills; self-starter; good decision-making skills and organizational skills. Technically competent to evaluate all products, including new and unique products, with assistance of other technical staff as necessary. Ability to manage multiple assessments and changing schedules and deadlines with supervision. Demonstrates technical competence [. .. ]
Job am 15.08.2025 bei Jobleads gefunden
(Senior) Quality Assurance Manager GCP (m/f/d)
• Frankfurt, Hesse
Work-Life-Balance
[. .. ] f/d) , you will be responsible for quality assurance within the R D departments at Merz Therapeutics, in accordance with applicable regulations including requirements for IT systems [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] used in clinical trials. This is a full-time position, and your key responsibilities will include: Development and maintenance of systems and tools supporting quality processes Quality management in accordance with GCP and IT regulations (e. g. , GAMP, 21 CFR Part 11) Planning and execution of audits, including reporting and CAPA follow-up Support with quality-related and IT-specific inquiries Ensuring compliance in global clinical development projects Preparation for and support during regulatory inspections Delivery of GCP training sessions as needed YOUR PROFILE Completed scientific degree or equivalent training Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance Sound knowledge of GCP requirements for the clinical development of drugs Good knowledge of MS Office, quality management processes Excellent communication skills, ability to work in a team, and a structured approach to work High level of responsibility, Strong team spirit and interest in [. .. ]
Job am 09.11.2025 bei Neuvoo gefunden
MEDICE Pharmaceuticals Pütter GmbH Co. KG
Global Quality PV GCP Manager (m/w/i)
• Iserlohn, North Rhine- Westphalia
Flexible Arbeitszeiten
[. .. ] Wir suchen eine erfahrene Fachkraft, die unsere globale Qualitätssicherung stärkt und insbesondere den Schwerpunkt GCP in unseren klinischen Entwicklungsprojekten verantwortungsvoll weiterentwickelt. In der Funktion agierst du als [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] QS-Schnittstelle zur Clinical Research-Abteilung und unterstützt beim Sponsor Oversight. Die Aufgaben im Detail: Lead Auditor bei GCP-Audits, einschließlich Planung, Durchführung, Berichterstattung und CAPA-Nachbereitung Planung, Organisation und Begleitung interner Audits zur Bewertung von Systemen, Prozessen, Aufzeichnungen und Kontrollen in der klinischen Forschung Effektive mündliche und schriftliche Kommunikation der Auditergebnisse sowie Berichtserstellung für das Management Entwicklung und Pflege von Systemen und Tools zur Unterstützung von Qualitätsprozessen im Einklang mit GCP- und QS-Vorgaben Sicherstellung der Compliance in globalen klinischen Entwicklungsprojekten Vorbereitung, Moderation und Nachbereitung behördlicher GCP-Inspektionen CAPA-Management aus Inspektionen inklusive Abstimmung mit Clinical Research sowie Einleitung und Nachverfolgung der Maßnahmen Durchführung von GCP-Schulungen Bewertung potenzieller Compliance-Risiken und Eskalation relevanter Qualitätsprobleme an das Management Vertretung der Qualitätssicherung in internen Meetings, beispielsweise in Trial-[. .. ]
Job am 07.11.2025 bei Neuvoo gefunden
Merz Therapeutics
(Senior) Quality Assurance Manager GCP (m/f/d) , (Senior) Quality Assurance Manager GCP (m/f/d) bei Merz Therapeutics softgarden
• Frankfurt, Hessen
Work-Life-Balance
[. .. ] f/d) , you will be responsible for quality assurance within the R D departments at Merz Therapeutics, in accordance with applicable regulations including requirements for IT systems [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] used in clinical trials. This is a full-time position, and your key responsibilities will include: Development and maintenance of systems and tools supporting quality processes Quality management in accordance with GCP and IT regulations (e. g. , GAMP, 21 CFR Part 11) Planning and execution of audits, including reporting and CAPA follow-up Support with quality-related and IT-specific inquiries Ensuring compliance in global clinical development projects Preparation for and support during regulatory inspections Delivery of GCP training sessions as needed YOUR PROFILE Completed scientific degree or equivalent training Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance Sound knowledge of GCP requirements for the clinical development of drugs Good knowledge of MS Office, quality management processes Excellent communication skills, ability to work in a team, and a structured approach to work High level of responsibility, Strong team spirit and interest in [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Clinical Compliance Auditor pro Jahr?
Als Clinical Compliance Auditor verdient man zwischen EUR 50.000,- bis EUR 70.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Clinical Compliance Auditor Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 17 offene Stellenanzeigen für Clinical Compliance Auditor Jobs.
In welchen Bundesländern werden die meisten Clinical Compliance Auditor Jobs angeboten?
Die meisten Stellenanzeigen für Clinical Compliance Auditor Jobs werden derzeit in Bayern (3 Jobs), Nordrhein-Westfalen (2 Jobs) und Baden-Württemberg (2 Jobs) angeboten.
Zu welchem Berufsfeld gehören Clinical Compliance Auditor Jobs?
Clinical Compliance Auditor Jobs gehören zum Berufsfeld Qualitätswesen.
