FDA Fellowship: Strategic Device Classification for TPLC

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 30,466 - 36,493; Full time

Benefits offered by this job

Monthly stipend commensurate with educational level and experience

Job summary

The Oak Ridge Institute for Science and Education is seeking candidates for a year-long research opportunity at the FDA in Silver Spring, Maryland. This role involves optimizing Total Product Life Cycle oversight by designing classification schemes for medical devices, which includes evaluating technologies and assessing benefit-risk profiles.

Successful candidates will hold or be pursuing a Master’s or Doctoral degree in various engineering fields. Full-time participation is required, and a monthly stipend will be provided.

Qualifications

• Currently pursuing or holding a master’s or doctoral degree in engineering or medical device-related fields.
• Understanding of medical devices and technologies.
• Ability to conduct comprehensive evaluations and design classification schemes.

Responsibilities

• Support optimization of Total Product Life Cycle oversight.
• Evaluate existing devices and their technologies.
• Design classification schemes for medical device regulation.
• Create benefit/risk-based product codes.

Skills

Research and analytical skills

Understanding of regulatory science

Strategic thinking

Technical writing

Project management

Education

Master’s Degree or Doctoral Degree in relevant field

Job description

The Oak Ridge Institute for Science and Education is seeking candidates for a year-long research opportunity at the FDA in Silver Spring, Maryland. This role involves optimizing Total Product Life Cycle oversight by designing classification schemes for medical devices, which includes evaluating technologies and assessing benefit-risk profiles.

Successful candidates will hold or be pursuing a Master’s or Doctoral degree in various engineering fields. Full-time participation is required, and a monthly stipend will be provided.