Head of Clinical Assay Development

Salary/Rate:€90,000 - €110,000 DOE
Job type:Perm
Business Sectors:Clinical, R&D, Biometrics
Job ref:24502
Post Date:12. 09. 2023

About the Role

Head of Clinical Assay Development

Our client located in Hamburg is currently looking for a Head of Clinical Assay Development to strengthen their team.

Become a part of a diagnostic company and support them with the development of products to detect traces of various diseases.

Your tasks:
  • In charge of creating and documenting RUO and IVD products (Kits) in accordance with ISO13485.
  • Responsible for the Clinical Assay Development team, its staff growth and development in accordance with departmental objectives.
  • Resource planning for tasks related to allocated R&D.
  • R&D process management and enhancement in accordance with applicable laws.
  • Coordinating duties between CAD and other departments or outside partners, if necessary
  • Adherence to appropriate quality system specifications.
  • Planning the budget, managing the infrastructure, and managing the expertise.

What is expected:
  • PhD in Molecular Biology or a similar field with a focus on Next Generation Sequencing and Oncology.
  • Experience related to area of responsibility, including new diagnostic assay development in a regulated environment.
  • Expertise with ISO 13485, FDA, and IVD regulations. 
  • Good understanding of workflow and laboratory processes.
  • At least 3 years of leadership experience.

What is offered:
  • International and innovative environment.
  • Hybrid flexibility.
  • 30 days’ vacation and relocation support.
  • Innovative and international culture with flat hierarchies and a caring atmosphere.
  • After-work events for international networking
  • A company that is focused on employee wellbeing.

Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology.