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