9 Jobs für Clinical Compliance Auditor
Stellenangebote Clinical Compliance Auditor Jobs
Job vor 3 Tagen 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 vor 7 Tagen bei Jobleads gefunden
• Saint- Sulpice, Waadt
[. .. ] 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 longterm 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 vor 9 Tagen 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
• 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 audit plans based [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 10.11.2025 bei Jobleads gefunden
• Iserlohn, Nordrhein- Westfalen
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 23.10.2025 bei Jobleads gefunden
• 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
• 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
• 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 05.07.2025 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 [. .. ]
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 9 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 Baden-Württemberg (2 Jobs), Nordrhein-Westfalen (1 Jobs) und Bayern (1 Jobs) angeboten.
Zu welchem Berufsfeld gehören Clinical Compliance Auditor Jobs?
Clinical Compliance Auditor Jobs gehören zum Berufsfeld Qualitätswesen.
