Scientist Pharma Research Inhalation MH

Job Description

Medical writing of the device related documentation

Experience with EU MDR Regulation

Experience drafting technical documentation for both US and EU (Technical files, GSPR, dossier sections)

Experience with ISO 13485 QMS, 21 CFR 820

Experience with drafting SOPs, technical protocols and reports

Experience with writing doc’s for Risk Assessments, Design and Process Verification, Biological Evaluation

Experience working in the Pharmaceutical Industry

Experience with drug-device combination products and design control documentation

Working with and managing relevant vendors

Work Experience

8-10Years

Education

Graduation in Science or Engineering

Competencies