Document Management Specialist - Frankfurt Am Main, Deutschland - Fresenius Medical Care

Fresenius Medical Care

Geprüftes Unternehmen

Frankfurt Am Main, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 backoffice 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