8 Jobs für Regulatory Documentation Writer
Stellenangebote Regulatory Documentation Writer Jobs
Job vor 6 Tagen bei Jobleads gefunden
The Associate Technical
Writer is responsible for developing, maintaining, and improving technical
documentation across service, engineering, customerorder, and internal documentation domains. The role ensures documentation is clear, accurate, userfocused, standardscompliant, [...]
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[...] and continuously improved through structured authoring and collaboration with crossfunctional teams. 1. Technical Documentation Development Develop and maintain assembly manuals, operating guides, maintenance manuals, troubleshooting guides, and service documentation. Apply structured authoring principles [. .. ] customerspecific documentation packages including: Spareparts lists, datasheets, technical certificates, schematics Installation and commissioning documentation, warranty and maintenance packs Manage revisions, approval workflows, and compliance requirements across multiple industries. 4. Standards Regulatory Compliance Ensure documentation aligns with relevant standards and regulatory requirements. Maintain complianceready technical files, safety content, and risk documentation. Support audits, conformity assessments, and documentationrelated regulatory activities. Coordinate document translation and localization with internal teams and external vendors. Maintain terminology consistency across all languages. Deliver highquality documentation in English. 6. [. .. ]
Job am 04.03.2026 bei Jobleads gefunden
[. .. ] will also develop market access content. You should be recognized as a brand expert with an ability to translate the science and data into compelling promotional copy [...]
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[...] complying with medical, regulatory, legal and compliance guidelines. The aim is to make the complex simple adapting larger pieces of content to create smaller, easy-to-read materials for digital and non-digital channels, maintaining key medical messaging and being able to anchor medical literature references. Creativity, innovative thinking, and problem-solving should be [. .. ] policies, ensuring that content development activities are supported by authentic and up-to-date references. Follow best practices in the department regarding processes, communication (internal and external) , project management, documentation and technical requirements such as language, grammar, stylization, content search, summarizing, data conflicts, and referencing. Participating in assigned training programs and working on assignments as per requirement. Participating in client calls as per project requirements. Use of, overseeing and harnessing the advantages of AI tools in providing accurate and relevant [. .. ]
Job am 22.02.2026 bei Jobleads gefunden
• Berlin
[. .. ] empowered to find creative solutions and make a meaningful impact on clinical development across rare disease, oncology, neurology, immunology and inflammation. About the Role We are seeking [...]
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[...] a Senior Medical Writer to join our Medical Writing and Pharmacovigilance Team and take ownership of clinical, regulatory and safety writing projects. This is a fulltime, hybrid role reporting to the Head of Medical Writing and Pharmacovigilance, with one to two days per week based in our Berlin office. Key Responsibilities Prepare a wide range of documents for global submission across all phases of clinical development and postmarketing, [. .. ] MDR) . Manage review cycles and project timelines in coordination with clients and internal stakeholders to meet delivery milestones. Act as a subject matter advisor on medical writing and regulatory documentation for clients and internal teams. Mentor, train and provide constructive feedback to junior writers to support their development. What You Will Need to Succeed Established experience as a medical writer within a CRO, biotech, pharmaceutical or medical device environment. Proven expertise in preparing at least three types of clinical, regulatory [. .. ]
Job am 11.01.2026 bei Jobleads gefunden
• München, Bayern
Direct message the job poster from i O Associates Senior Consultant Partnering with Businesses in Germany Switzerland Technical
Writer-S1000D (m/f/d) Permanent Full-time Germany-wide We are seeking Technical Writers with strong [...]
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[...] S1000D exposure to support complex, safety-critical engineering programmes. This role is ideal for professionals who enjoy working close to engineering, translating technical data into structured, compliant documentation for end users and maintainers. Responsibilities Creation, authoring, and maintenance of technical documentation in accordance with ASD S1000D Working with data modules, business rules, and document structures within S1000D environments Independent on-site analysis and information gathering at customer or project locations Interpretation of engineering drawings, CAD models (2d/3D) , parts lists, and technical specifications Creation and optimisation of illustrations and graphics to explain complex technical systems Ensuring documentation compliance with quality, configuration, and regulatory requirements Close collaboration with engineering, logistics, and project stakeholders Required Qualifications Experience Technical education, state-certified technician, or engineering degree Proven experience as a Technical Writer in an S1000D environment Background in aerospace, defence, or naval systems is highly desirable Understanding of S1000D concepts such as: Applicability and business rules; [. .. ]
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 Tech [...]
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[...] start-up (Cor Lector Gmb H) based in Nuremberg that develops software solutions for cardiology. Our products are about to be approved, which is why [. .. ]
Neu Job vor 4 Std. bei Neuvoo gefunden
Excelya
Freiberuflich
[. .. ] step into a career-defining role in Medical Affairs. Ready to make an impact that travels the globe? Lets talk. About the Job We are seeking a Freelancer [...]
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[...] Senior Medical Writer, experienced with medical devices, for a part-time fully remote role, to provide medical and scientific expertise required for the successful completion of Excelyas projects. Your Mission: Lead the preparation and review of key medical device documentation, including PMCF plans/ reports, PSURs, CERs, and PMS reports for class IIA, IIB and III medical devices. Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation. Provide expert medical and scientific input across projects, ensuring compliance with MDR requirements and supporting transitions from MDD to MDR. Respond to regulatory authority queries with clear, evidencebased medical justifications. Collaborate with crossfunctional teams to support studyrelated documentation (protocols, study reports) for medical device projects. Participate in [. .. ]
Job am 07.03.2026 bei Neuvoo gefunden
Dr. Falk Pharma GmbH
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] gastroenterological and hepatic diseases. To bridge the divide from clinical research to clinical practice, we are looking for a qualified and motivated individual to translate clinical science [...]
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[...] for healthcare professionals, regulatory authorities, and other internal and external stakeholders. You are a healthcare enthusiast who is capable of adeptly assimilating and interpreting clinical efficacy and safety data or other scientific content into a logical, scientifically balanced compelling medical narrative for the appropriate audience. Your tasks: Planning, writing, reviewing and submitting manuscripts on [. .. ] Track record of authoring or providing writing assistance for scientific publications in peer-reviewed journals Experience in clinical research, including knowledge of ICH E6 guidelines and familiarity with clinical trial documentation Strong familiarity with biostatistics Full English verbal and written proficiency as well as working proficiency in German Ability to work regularly in the Freiburg office is desirable Independent and structured way of working, strong communication skills, empathetic and supportive Proficiency in Microsoft Office, expertise in productivity tools and data visualization [. .. ]
Job am 27.02.2026 bei Neuvoo gefunden
HELM AG
• Hamburg
[. .. ] (m/f/d) with a clinical life science background. In this position, you combine scientific expertise with strategic thinking, you help shape a highquality development pipeline and contribute to [...]
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[...] strong regulatory outcomes. You will work closely with interdisciplinary teams and external partners to drive projects forward efficiently. This role offers you the opportunity to actively influence clinical development decisions and create real value for customers. Become part of a dynamic environment where your work has a real impact Your tasks: You [. .. ] This also includes consultation and design of trial concepts with competent authorities and the preparation of scientific advice packages. Part of your role will also include tasks as a Medical Writer, where you prepare and review scientific documentation on the efficacy and safety of our products. Here, you ensure the timely preparation of nonclinical and clinical documentation for regulatory submissions, including the commissioning and review of modules 2.4 and 2.5. In doing so, you respond to deficiency letters during registration procedures and manage corresponding customer inquiries. [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Regulatory Documentation Writer pro Jahr?
Als Regulatory Documentation Writer verdient man zwischen EUR 45.000,- bis EUR 70.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Regulatory Documentation Writer Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 8 offene Stellenanzeigen für Regulatory Documentation Writer Jobs.
In welchen Bundesländern werden die meisten Regulatory Documentation Writer Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Documentation Writer Jobs werden derzeit in Berlin (1 Jobs), Niedersachsen (1 Jobs) und Baden-Württemberg (1 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Documentation Writer Jobs?
Regulatory Documentation Writer Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
