IVD CE Marking Specialist – Molecular Oncology (Remote)

BSI; United States; On-site; USD 119,000 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

401(K) with company contribution

Short-term disability

Long-term disability

Parental leave

Job summary

BSI is seeking a Technical Specialist for CE marking within the IVD field, focusing on molecular oncology and CDx. The role combines design and regulatory leadership with hands-on technical reviews in a home-based setting with travel as needed.

The ideal candidate holds a bachelor’s degree or higher in a relevant discipline and has 4+ years of post-graduate experience in IVD device design and development, including risk management, design controls, and regulatory knowledge.

Qualifications

• Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use.
• At least 4 years' post-graduate experience in the design and development of IVD medical devices, incl. design control and risk management.
• Knowledge of medical device regulations and awareness of certification processes, quality management standards, and audits.

Responsibilities

• Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise.
• Deliver technical reviews and 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.

Skills

IVD design & manufacture

Regulatory knowledge

Quality management

Risk management

Clinical evaluation

Education

Bachelor's degree or higher in a relevant discipline

Job description

BSI is seeking a Technical Specialist for CE marking within the IVD field, focusing on molecular oncology and CDx. The role combines design and regulatory leadership with hands-on technical reviews in a home-based setting with travel as needed.

The ideal candidate holds a bachelor’s degree or higher in a relevant discipline and has 4+ years of post-graduate experience in IVD device design and development, including risk management, design controls, and regulatory knowledge.