In-vitro diagnostics Scientist @ Danaher

Job Information

Job Description:

Your Key Responsibilities:

  • Provide guidance to product development and product life cycle management under direction of Design Control;
  • Act as representative for all Quality Management activities for new product development projects;
  • Review, revise and approve documentation consistent with design control regulations, Quality Management System (QMS) policy and Standard Operating Procedures (SOPs);
  • Documentation for IVDR, customer requirements, product requirements, design and development plans and reports, non-clinical protocols and reports, design transfer documents, labeling, clinical plan and reports, risk management plans and reports, project plans and milestones;
  • Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy;
  • Participate in discussions, challenge the status quo, and identify mutually beneficial compliant solutions/compromises with cross functional colleagues at the Project Team level. Work closely and partner with Danaher and LBS colleagues in product development teams with the goal of leveraging expertise and alignment on best practices;

Your Background:

  • Bachelor’s or Master´s Degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline or equivalent combination of education and work-related experience. PhD is preferred.
  • A minimum of 2-3 years (preferably minimum 5 years) of experience in regulated industry – in-vitro diagnostic (IVD) products or related medical devices, pharma or clinical research – with high involvement in the new product development or leading new product development;
  • Knowledge of or affinity with quality regulations, medical devices, clinical or pharma processes is preferred;
  • Strong track record of successful participation in cross-functional teams and projects;
  • Good familiarity with Design Controls and ISO: ISO 13485 and Risk Management ISO 14971;
  • Experience with human cytogenetics and/or (F)ISH (Fluorescent In Situ Hybridization), histological/ immunohistochemical, pathology and molecular biology techniques and their use in clinical diagnostic settings is highly desirable;
  • Knowledge of the main regulations, such as EU IVDR and/or MDR, EU IVDD and/or MDD is highly desirable;
  • Excellent communication skills and full working proficiency in the English language (C1 level) is essential, any other language proficiency is a plus.

Experience Level: Junior/Associate
Work From: Onsite

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