Job Title-Technical Specialist- IVD (In Vitro Diagnostic)Location: United States- HomebasedBSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are seeking people with knowledge of the design and manufacture of IVD Molecular oncology and CDx
Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety - this may be a great fit for you! This is a
home-based position with some travel
Essential Responsibilities:- Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
- Deliver technical reviews, scheme management in support of the CE marking schemes
- Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
- Provide "Technical Sales/Networking" support to the commercial team
The ideal candidate will possess the following characteristics:- Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification.
- At least (4) years' post-graduate experience in the design and development of IVD medical devices, including the principles of design control, risk management and performance and/or clinical evaluation primarily focusing on IVD Molecular oncology and CDx
- Knowledge of medical device regulations.
- Awareness of certification business processes, the application of quality management standards, and audits
BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 20-days annual leave, bank holidays, medical, dental, vision, and life insurance, 401(K) with company contribution, short-term and long-term disability, maternal leave, paid parental leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.
The salary for this position can range from $119,400 to $140,000 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons.
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