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 is 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 from an IVDR perspective
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