Compliance Officer

**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

Osaamisalue: Hallinto- & toimistotehtävät, Tutkimus, kehitys & tuotekehitys