Medical Device Documentation Specialist (m/f)

REFERENZNUMMER:

262514/11

IHRE AUFGABEN:

-Dealing with COREMAP requirements in device development for documents, adopt documents to archival requirements and clean-up activities
-Support the documentation and compliance Group in preparing documents for Quality System Documentation, establish and maintain Technical Documentation according requirements outlined in the Medical Device Directive and 21 CFR820 for Medical Devices and Design History Files
-Training administration
-Actively contribute to improvement of documentation management systems, business processes and procedures, ensure Good Documentation Practices
-Perform any other tasks as requested by Management to support documentation and compliance activities

IHRE QUALIFIKATIONEN:

-Experience in working in pharmaceutical, biotech, diagnostics, medical device or healthcare industry under cGxP, QSR or similar working practices
-Excellent knowledge of cGMP`s and relevant international regulatory requirements, quality system experience
-Excellent documentation management and documentation skills
-Sound knowledge of Quality Systems Regulations including device design controls, and Medical Device Directives (e.g. ISO 13485 and FDA CFR 21 Part 11, Part 820)
-Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
-Excellent IT knowledge

WEITERE QUALIFIKATIONEN:

Quality manager