Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. As a global health care company, we have
a special goal: provide the best possible care. Join us to improve the quality of life for a growing number of patients around the world and be a vital part of our team.
…+ <- Sailauf / Bayern · Permanent · Full-time · As of now Document Management Specialist (m/f/d) In your role as Document Management Specialist (m/f/d) you will be responsible for ensuring the Implementation and Maintenance of Product Documentation in compliance to regulatory and quality system requirements. Your assignments Supporting conformity assessment procedure acc. to MDD and MDR as well as Product Center Management Activities (e. g. Regulatory Compliance and PMS Activities) Preparation and Maintenance of Technical Documentation or other Regulatory Documentation Composing technical and risk management related content of clinical evaluation Support and Management of requests for technical documentation, STED and other registration purposes from various FME departments (e. g. usability, medical, verification testing, biocompatibility, labelling) Support of Product Design Changes and Execution of corresponding activities Responsible for Preparation and Review of Regulatory Content for Accompanying Documentation (e. g. Instructions for Use, Service Manual) Supporting function in case of Notified Bodies / Authorities audits (e. g. preparation of documentation for audits, supporting back-office during audits) Ensure consistent Implementation of tools & methodologies for Product Documentation (e. g. GPDM Windchill and Polarion) while adhering to quality and compliance requirements; interface with design quality assurance and regulatory groups as needed Your profile Successful completed bachelor's or master's degree First professional experience in Product Development, Quality Management or Conformity Assessment of medical device or other regulated products Knowledge of relevant regulations and guidelines such as MDD, MDR, ISO13485, 21 CFR 820 and ISO14971 as well as knowledge of R&D related processes and methodologies (e. g. Conformity Assessment, Product Risk Management, Design Quality Assurance) are an asset Ability to solve problems and courage to lead Strong interpersonal skills and capable in dealing with ambiguity High degree of independence and personal responsibility Good knowledge in written and spoken English and German (B2 Level) Willingness for occasional business trips, mainly in the national area Apply now Share this job Print this Page Your Contact Saskia Derleth VIVONIC GmbH Ref. number 56402 At a glance Career level: Graduates, Professional Experienced Job category: Quality Management / Environment, Other Working condition: Permanent / Full-time Business segment: Fresenius Medical Care Location: Sailauf / Bayern Closing date for application: none - we look forward to your application More information Information about the application process Our offer at a glance «The questions that take top priority in our work are how to best listen to our patients' voice, recognize their needs and gear our processes towards them. It's a very fulfilling role.« Sandra Löber Program Manager Medical Sustainability, Fresenius Medical Care Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care. freseniusmedicalcare.com We welcome diversity At Fresenius all job applicants are welcome - regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse). #careerswithapurpose at Fresenius Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. Vivonic GmbH https://files.relaxx.center/kcenter-google-postings/kc-18317/logo_google_medicalcare.png 2023-07-15T10:34:41.626Z FULL_TIME EUR YEAR null 2023-05-16 Sailauf 63877 Kurfürst-Eppstein-Ring 4 50.00483240000001 9.2413858