About The Position
This is a broad, hands-on internship for someone who wants to see how a medical device actually gets to market. Over six months you will work with consultants on live client engagements spanning regulatory strategy, quality and compliance, clinical study design, and technical documentation. Consulting rewards people who can move between unfamiliar problems quickly, and this internship is built to find out whether that describes you. The work touches a mix of software-only SaMD, embedded firmware in Class II/III devices, and traditional hardware devices. The clients range from a founder who has never spoken to FDA to seasoned regulatory teams who need an extra pair of hands to move a project forward. We hire interns with the intention of converting them. This role is a working audition for a Consultant I position, and we will tell you throughout the term how you are tracking against that bar.
Requirements
- Ability to move between unfamiliar problems quickly.
- Familiarity with software-only SaMD, embedded firmware in Class II/III devices, and traditional hardware devices.
- Ability to critically read client documentation and flag unsupported, vague, or inconsistent information.
Responsibilities
- Support consultants across the full range of Advisory Services work.
- Conduct research and analysis feeding regulatory strategy, including predicate searches, classification questions, competitor clearance analysis, and guidance and standards review.
- Draft sections of client deliverables under consultant review, such as Pre-Submission packages, 510(k) sections, gap assessments, requirements and traceability documentation, and study protocols and synopses.
- Critically read client documentation and flag unsupported, vague, or inconsistent information relative to the product's actual function.
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What This Job Offers
Career Level
Intern
Education Level
No Education Listed
