Regulatory Affairs Clinical Writing Professional (w/m/d)
Fresenius SE & Co. KGaA
- Vollzeit – Unbefristet – Mobiles Arbeiten teilweise möglich – Als Regulatory Affairs Clinical Writing Professional übernehmen Sie eine Schlüsselrolle in der klinischen Bewertung und klinisch‑regulatorischen Dokumentation unserer Medizinprodukte. Sie gestalten den gesamten Produktlebenszyklus aktiv mit – von der Planung klinischer Bewertungen über die Erstellung zentraler Dokumente bis hin zur Post‑Market‑Surveillance. Ihre Arbeit trägt direkt dazu bei, Sicherheit, Leistungsfähigkeit und regulatorische Konformität unserer Produkte weltweit sicherzustellen. Aufgaben und Verantwortlichkeiten Klinische Bewertungen erstellen und aktualisieren über den gesamten Produktlebenszyklus Regulatorische Anforderungen sicherstellen (EU MDR, FDA) Studienprotokolle entwickeln inkl. Ein-/Ausschlusskriterien, Endpunkten und Methoden, sofern erforderlich Interdisziplinär zusammenarbeiten mit R&D, RA, QA und Marketing Literaturrecherchen und Datenanalysen durchführen zur klinischen Evidenz Risikobewertungen durchführen und in die klinische Bewertung integrieren Post‑Market‑Surveillance unterstützen (PMS‑Pläne, PSURs, PMCF, Trendanalysen) Fachliche Qualifikationen und Kompetenzen Abgeschlossenes wissenschaftliches Studium (Medizin, Biomedizintechnik, Naturwissenschaften o.Ä.) Fundierte Kenntnisse klinischer Forschung und Regulierung im Medizinproduktebereich Erfahrung mit statistischen Auswertungen und klinischen Bewertungsmethoden Starke Projektmanagement‑ und Kommunikationsfähigkeiten Selbstständige, strukturierte und zuverlässige Arbeitsweise Teamfähigkeit in interdisziplinären und internationalen Umfeldern Hohe Detailgenauigkeit und Qualitätsbewusstsein #J-18808-Ljbffr Fresenius SE & Co. KGaA
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Clinical Writing Professional (w/m/d) in New Bremen, OH vacancy
- Fresenius SE & Co. KGaA sucht einen Regulatory Affairs Clinical Writing Professional, der eine Schlüsselrolle in der klinischen Bewertung und regulatorischen Dokumentation von Medizinprodukten übernimmt. Verantwortungen beinhalten die Erstellung und Aktualisierung klinischer...SuggestedRemote job
€120k - €140k per year
Director Clinical Operations, Trial Management and Oversight (m... ...quality (Medical Services, Regulatory Affairs, Trial Supplies, Bioanalytics... ...stage to the final report writing, and archiving Ability to... ...flexibility, ownership, and professional growth within a supportive...SuggestedFull timeWork experience placementInterim role- ...Zusammenarbeit mit Entwicklung, Applikation und Regulatory Affairs tragen Sie zur Weiterentwicklung und... ...Anpassung und Verbesserung von Clinical Affairs Prozessen Erstellung von PMS-... ...Qualifikation Praxiserfahrung im Medical Writing von Vorteil Kenntnisse der relevanten...SuggestedFlexible hours
$59k - $61k
Clinical Fellow Speech-Language Pathologist Odessa, DE Clinical Fellowship Speech-Language... ..., AAC resources, and experienced professionals committed to helping early-career SLPs... ...therapy services Conducting evaluations and writing reports Collaborating with...SuggestedWeekly payFull time- Job Description Summary As a Regulatory Affairs Leader, you will be supporting GE HealthCare's Women... ...(including product testing, clinical data, etc.), product claims and country... ...regulatory requirements. Contribute to writing and editing technical documents. Research...Suggested
- SymBio. sucht einen Regulatory Affairs Professional (m/w/d) für ein internationales Beratungsunternehmen in der Pharma- und Medizintechnik. Zu den Aufgaben gehören die nationale Zulassung und Registrierung von Diagnostikprodukten, die Erstellung technischer Dokumentationen...Remote jobFlexible hours
- Regulatory Affairs Professional (m/w/d) - Diagnostik - remote mit Reisebereitschaft Für ein international tätiges Beratungsunternehmen in der Pharma- und Medizintechnikindustrie, suche ich ab sofort einen Regulatory Affairs Manager (m/w/d) in unbefristeter Festanstellung...Remote workFlexible hours
- Technical Regulatory Affairs Professional (d/f/m) Location: Herzogenaurach, DE, 91074 Regensburg, DE, 93055 Job Requisition ID: 40516 Schaeffler is a dynamic global technology company and its success has been a result of its entrepreneurial spirit and long history of...Worldwide
- .... Our cutting‑edge science and robust clinical pipeline form the broadest PRAME franchise... ...seeking an Associate Director Regulatory Affairs - Clinical Lead* to strengthen our EU... ...believe in supporting our employees’ professional and social skills: We enable them to join...Summer workRemote workRelocation package
- ...regulations. Prepare and submit reports to regulatory bodies, senior management, and other... ..., and services. Deep experience in writing and maintaining policies based on official... ...written and oral. Work Experience 5+ years professional experience in Compliance (IT Audit,...Work experience placement
€2,000 - €3,000 per month
...Proficiency in Microsoft Office (Word, Excel). Research abilities (writing reports, editing, analyzing). Comfortable working with AI... ...with a diverse, international team of highly experienced professionals. Remote work for an international company. Employment Type...Contract workWork experience placementWork at officeRemote work- ...and budget Leads the regional clinical operations team (including... ...managers, country heads, medical affairs and any other stakeholders... ...ensure timely submission to regulatory authorities and ECs/IRBs Accountable... ...Study Manager and Medical Writing Quality Handles escalated...Local area
- ...Named Patient Use (NPU) requests from a clinical and ethical perspective, ensuring robust... ...focussed on the development of high-quality regulatory documentation (CTD) and support of... ...rheumatology or immunology Exceptional medical writing and storytelling capability Strong...Remote workFlexible hours
- ...research quality, and AI-driven workflows. We are looking for a Professional Content Creator who can create engaging, educational, and high... ...and engaging posts about AI tools and productivity Write SEO optimized articles and website content Create scripts for...
- A global biopharmaceutical leader is seeking an Associate Director Regulatory Affairs - Clinical Lead to enhance their regulatory team in EU. In this pivotal role, you will manage the EU regulatory strategy for innovative oncology programs within a dynamic and collaborative...Remote job
- ...leveraging AI tools for efficiency. The role requires 3-5 years of copywriting experience, particularly for lifestyle and ecommerce brands. You’ll collaborate closely with creative teams and SEO professionals to ensure brand consistency. #J-18808-Ljbffr Alumni VenturesFreelance
- ...Transcatheter Mitral & Tricuspid Therapies (TMTT) clinical study execution including leading the... ...ready environment for all aspects of regulatory and non‑regulatory audits as it relates... ...to detail Ability to interact professionally with all organizational levels and proactively...Work experience placementWork at officeRemote workFlexible hours
- ...manage contract deliverables with a focus on quality and efficiency. This role involves reviewing and negotiating contracts related to clinical trials, collaborating with teams to assess risks, and maintaining accurate records. Applicants should have a Bachelor's degree and...Contract work
- Nature Heart ist auf der Suche nach einem erfahrenen Health Copywriter, der für die Erstellung von verkaufsstarken Texten im Bereich Gesundheitsprodukte verantwortlich ist. Die Position bietet 100 % Remote-Arbeit und unbefristete Vollzeitanstellung. Ideale Bewerber haben...Remote jobFlexible hours
- ...for a Associate Director, Operations - Clinical Assessment Technologies (CAT) based in... ...while ensuring compliance with global regulatory standards. Operating in a fast‑paced, international... ...emphasizing innovation, diversity, and professional growth. Opportunity to contribute to...
- Job Title Clinical Development Scientist Job Description Job Responsibilities Owns and drives... ...TPP, claims, endpoints, and evidence to regulatory acceptance and post‑market requirements... ...and analysis. Experience in Medical Writing (CER, CSR, PMCF) and/or Scientific Publications...
- Clinical Development ScientistSkip to main content# CareersClinical Development Scientist... ...TPP, claims, endpoints, and evidence to regulatory acceptance and post‐market requirements... ...research and analysis.* Experience in Medical Writing (CER, CSR, PMCF) and/or Scientific...3 days per week
$80k - $90k
...are currently seeking a high-performing Clinical Coordinator for a premier ABA clinic in... ...collection, trend analysis, and report writing. Physical Demands: This is an active clinic... ...to fostering an inclusive and diverse professional environment. #J-18808-Ljbffr ReliatusTemporary work- ...independently plans and prepares a range of regulatory documents and medical communications to... ...works under the direction of Medical Writing management and collaborates with cross-... .../biotechnology research setting. Other professional and/or educational experience may...Contract workWork at officeRemote workWorldwideFlexible hours
- SME Careers is seeking a Compliance & Regulatory Subject Matter Expert for a remote contractor role. The expert will review AI-generated... ...a Bachelor’s degree, 5+ years in compliance roles, and strong writing skills. Responsibilities include developing AI training...Remote jobFor contractors
- Professional Internal Audit (d/m/w) - Methoden, Reporting & Qualitätssicherung Herzogenaurach, DE, 91074 ID Stellenanforderung: 42715 Schaeffler - das ist die Faszination eines internationalen Technologie-Konzerns, verbunden mit der Kultur eines Familienunternehmens....Flexible hours
- ...von Zulassungsverfahren. Erforderlich sind ein abgeschlossenes Studium in Medizin oder verwandten Bereichen, Erfahrung im Medical Writing und ausgezeichnete Deutsch- sowie Englischkenntnisse. Genießen Sie flexible Arbeitszeiten und zahlreiche Benefits in einem innovativen...Flexible hours
- ## Validation & Compliance Professional (m/f/d)Applylocations: Martinsriedtime type: Full timeposted on: Posted 18 Days Agojob requisition... ...and inspections, ensuring compliance with internal and regulatory requirements* Manage and support GMP/GCLP procedures, including...Work experience placementWork at office
- ...or international studies and clinical projects (e.g. Study... ...care* Active participation and professional support at commercial meetings... ...Strong experience in Medical Affairs* Experiences in Dermatology/... ...scientific background* Knowledge of Regulatory Affairs, Pharmacovigilance,...Local area
- Trilogy Writing & Consulting is looking for a Senior Quality Control Specialist (f/m/d) to oversee quality control for regulatory documents in the international pharmaceutical industry. This role can be onsite or remote. Qualified applicants must have at least 3 years of...Remote job
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Clinical Writing Professional (w/m/d). Be the first to apply!
Related searches
- regulatory New Bremen, OH
- food regulatory New Bremen, OH
- regulatory contract New Bremen, OH
- regulatory technician New Bremen, OH
- regulatory scientist New Bremen, OH
- regulatory engineer New Bremen, OH
- regulatory law New Bremen, OH
- compliance reviewer New Bremen, OH
- vp compliance New Bremen, OH
- regulatory affairs consultant New Bremen, OH