Lead Study Director for Medical Device Testing

Nelson Laboratories, LLC in; Taylorsville (UT); On-site; USD 90,000 - 140,000; Full time

Job summary

Sotera Health seeks a Study Director II to lead medical device and healthcare-related testing studies, ensuring scientific quality, regulatory compliance, and outstanding client service. You will oversee studies from initiation to final reporting, coordinating with customers, lab personnel, quality teams and cross-functional partners.

The ideal candidate combines strong scientific expertise with leadership, communication, and project management skills, and can mentor staff in a fast-paced,

Qualifications

• Strong scientific reasoning and analytical skills.
• Exceptional technical writing and documentation abilities.
• Excellent verbal communication and presentation skills.
• Ability to explain complex scientific concepts to both technical and non-technical audiences.

Responsibilities

• Serve as the primary scientific lead and single point of control for assigned studies.
• Direct the technical execution of studies from initiation through final report issuance.
• Review, interpret, analyze, and communicate study results.
• Prepare, review, and approve technical reports and study documentation.
• Collaborate on test method development, validations, and equipment validations.
• Review and approve customer specifications and study requirements.

Skills

Scientific leadership

Project management

Regulatory compliance

Customer communication

Technical writing

Education

Masters degree in Life Sciences or related

Bachelor's in Life Sciences + Study Director exp

Job description

Sotera Health seeks a Study Director II to lead medical device and healthcare-related testing studies, ensuring scientific quality, regulatory compliance, and outstanding client service. You will oversee studies from initiation to final reporting, coordinating with customers, lab personnel, quality teams and cross-functional partners.

The ideal candidate combines strong scientific expertise with leadership, communication, and project management skills, and can mentor staff in a fast-paced,