About this role
**Responsibilities:** · Update/correct products related documentation for all departments including production · Coordinate IVDR activities for document completeness as per IVDR requirements · Plan and undertake internal quality audits · Support QA team on documentation update · Coordinate PMS (Post Market Surveillance) activities with internal and external customers · Compilation of product related data for Performance Evaluation Reports (PER) for IVDR compliance · Implement processes as per periodical update of IVDR with appropriate documentation **Skills & Qualifications:** - Masters in Science in Chemistry, Biochemistry, Microbiology or a similar field - Good communication skills - oral and written in English, Finnish proficiency will be an added advantage - Strong interpersonal skills with the ability to influence others - Familiarity with the new European IVDR Directive - Knowledge of MS Office tools, and technology related software - Knowledge of Medical Devices/IVDR regulatory affairs discipline throughout the product lifecycle, including Design, Development, Labelling, Marketing, Launch and Commercialization - Familiarity with Regulatory Authority policies and guidance and apply them as appropriate in product development and commercialization Business orientation and ability to see the business drivers form IVDR perspective