6 Jobs für Regulatory Affairs Writer
Stellenangebote Regulatory Affairs Writer Jobs
Neu Job vor 4 Std. bei Jobleads gefunden
• Frankfurt, Hesse
ICON Beijing/ Shanghai Sr. Medical
Writer ICON plc is a worldleading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and excellence, and we [...]
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[...] welcome you to join us on our mission to shape the future of clinical development. As a Senior Medical Writer at ICON, you will lead the [. .. ] applying your expertise to complex challenges. Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs) , investigator brochures (IBs) , and regulatory submissions, ensuring accuracy, clarity Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives. Contributing to the development of publication plans, abstracts, [. .. ]
Job am 12.04.2026 bei Jobleads gefunden
• Bargteheide, Schleswig- Holstein
Teilzeit Abgeschlossenes Studium
Betriebliche Altersvorsorge Mitarbeiterevents
Manager Quality
Regulatory Affairs (m/w/d) - Voll-oder Teilzeit (min. 25 h) Weiterentwicklung des Qualitätsmanagementsystems (QMS) für Medizinprodukte und Qualitätsmanagementhandbuchs (QMH) Erstellung, Prüfung und Schulung SOPs unter Beachtung der gesetzlichen und [...]
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[...] normativen Regelungen hinsichtlich der MDR, FDA ISO 13485 Gestaltung und Überwachung des Konformitätsbewertungsprozesses gemäß MDR, FDA ISO 13485 Vorbereitung, Durchführung und Nachbereitung interner und externer Audits Beteiligung an Produktentwicklungsprojekten und Unterstützung der technischen Abteilungen bei regulatorischen Fragestellungen Steuerung der Dienstleister, insbesondere Testlabore und Medical Writer Erfahrung im Qualitätsmanagement oder Regulatory Affairs in der Medizintechnikbranche oder einem ähnlichen Umfeld Verständnis der Prinzipien und Anforderungen von MDR und ISO 13485 Studienabschluss in Ingenieurwissenschaften, Life Sciences, einer ähnlichen technischen Studienrichtung oder gleichwertige praktische Erfahrung Teamplayer mit umfassenden Kommunikations- und Problemlösungsfähigkeiten Arbeits- und Kommunikationsfähigkeit in Wort und Schrift in [. .. ]
Job am 05.04.2026 bei Jobleads gefunden
• Berlin
About The Opportunity The Senior Manager, Business Audit supports internal audit activities across the N26 group, including external contractors and subsidiaries, in line with professional and
regulatory standards. Key responsibilities [...]
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[...] include developing and executing a comprehensive riskbased annual audit plan, managing the full audit cycle to ensure operational effectiveness, compliance, and reliability, and auditing both inhouse and outsourced processes. The position requires preparing detailed audit reports, regularly communicating findings and agreed actions to management and committees, monitoring [. .. ] stakeholders and to withstand management pushback. Proficiency in audit tools, data analytics, and reporting systems. Deep understanding of operational and financial (key) controls, process optimisation, and risk mitigation. Strong report writer focus on legal and factual subsumption. Robust and defensible reporting. Audit leadership and audit quality assurance. Whats In It For You Accelerate your career growth by joining one of Europes most talked about disruptors. Employee benefits that range from a competitive personal development budget, work from home budget, discounts to [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. [...]
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[...] Job Function Medical Affairs Group Job Sub Function Medical Writing Job Category People Leader All Job Posting Locations Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, South Holland, Netherlands, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description About [. .. ] Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https:/ / Associate Director, Regulatory Medical Writing, Oncology Requisition Numbers United States Requisition Number: R-061111 United Kingdom Requisition Number: R-062446 Switzerland Requisition Number: R-062450 Netherlands Belgium Requisition Number: R-062452 Canada Requisition Number: R-062453 Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose Able to function as a lead writer on any compound independently. Leads in setting functional tactics/ strategy. Leads project-level strategy (eg, submission team, global program team, clinical team) . May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority. Able to write and coordinate complex [. .. ]
Job am 02.02.2026 bei Jobleads gefunden
• Wiesbaden, Hessen
[. .. ] areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at Job [...]
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[...] Description The HTA Writer is responsible for providing clinical EUHTA document support to the JCA core team, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process. Provides HTA writing expertise for multiple compounds and/or projects, expertise in HTA, oncology is a plus within a therapeutic area. Interfaces with JCA core and extended teams (e. g. , HTA Strategy, Access, DSS HTA Stats, VAC, HEOR Strategy, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/ delivery of information and review of EUHTA submissions. Responsibilities Able to write less complex document types (unmet need, disease burden sections) , with little supervision. Requires close supervision/ mentoring on more complex document type and relies on review of subject matter experts and [. .. ]
Job am 21.12.2025 bei Jobleads gefunden
Freiberuflich
Freelance Technical
Writer (m/f/d) Medical Technology/
Regulatory Documentation Germany Freelance Technical Writer (m/f/d) Medical Technology/ Regulatory Documentation Remote Start: immediately Project-based/by arrangement About us We are an innovative Med [...]
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[...] Tech start-up (Cor Lector Gmb H) based in Nuremberg that develops software solutions for cardiology. Our products are about to be approved, which is [. .. ] technical documentation for MDR and FDA approvals. Structuring and editing documents such as instructions for use, risk management documents, clinical evaluations and software documentation. Working closely with the development, regulatory affairs and quality management departments. Ensuring compliance with applicable standards and regulatory requirements (e. g. ISO 13485, IEC 62304, ISO 14971) . Supporting the optimization of our documentation processes and structures. Your profile Several years of experience in technical writing, ideally in the medtech or life science environment. Profound knowledge of [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Regulatory Affairs Writer pro Jahr?
Als Regulatory Affairs Writer verdient man zwischen EUR 45.000,- bis EUR 65.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Regulatory Affairs Writer Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 6 offene Stellenanzeigen für Regulatory Affairs Writer Jobs.
In welchen Bundesländern werden die meisten Regulatory Affairs Writer Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Affairs Writer Jobs werden derzeit in Hessen (1 Jobs), Sachsen-Anhalt (1 Jobs) und Berlin (1 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Affairs Writer Jobs?
Regulatory Affairs Writer Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
