Design Control Expert
Recruitment Consultant in Herent
+32 16 30 95 09
As Design Control Expert, you provide hands-on support in implementation of the updated design and development policy and associated processes within new and ongoing development projects.
Your responsibilities are related to develop the organization to implement design control in a risk based manner. You will support project teams from design control and compliance perspective.
You will interact primeraly with the IIIP core team and the QA R&D manager.
- Provide hands-on guidance to the teams to implement the updated (as part of IIIP) IVD design and development process and associated procedures in new and ongoing projects.
- Provide input from a Quality perspective to ensure safety and effectiveness throughout Design Control
- Provide input from a Compliance perspective to ensure compliance to FDA and IVDR guidelines
- Help to identify knowledge gaps within the teams in function of the updated IVD Development Processes: hands-on guidance and training
- Help to identify knowledge gaps with the teams on how to ensure traceable, standardized and consistent reporting throughout the corresponding documentation: hands-on guidance and training
- Help to establish recurrent training on Design Control in collaboration with the process owner(s): General training in alignment with design control expert training
- PhD in in Pharmaceutical, Biomedical, (Bio)chemical or Biological sciences, or equivalent by training
- At least 5 years industrial experience with IVD Development, preferably IVDs in the area of Molecular Diagnostics
- Strong knowledge of international regulatory standards (ISO, CLSI, FDA)
- Experience with IVD product development
- Change management experience
- Industrial experience with FDA submissions of Molecular Diagnostics is a plus
- Perfect knowledge of English, any other European language is considered as asset
- Product development according to design controls (ISO 13485)
- Product risk management (ISO 14971)
- Understanding and knowledge of the applicable regulatory guidelines (21 CFR part 820 and IVDR)
- Excellent Operational Excellence mindset
- Strong communication skills to provide training to a large audience of people with various levels of education
- Strong educational skills to clarify and help translate design control requirements into product development projects with respect to the applicable regulations, recommendations and standards
- Methodical and process minded. Execution, results and improvement oriented
- Excellent interpersonal and team working skills
- Collaborative problem solver, handles conflict constructively
- Proactive attitude
- Able to work under pressure and have a flexible approach