Principal Consultant
RemoteUnited States
Job Summary
Lead technical discussions and drive program execution for combination product development, aligning initiatives with industry standards, regulatory requirements, and site quality management systems. Develop design control deliverables to document compliance with medical device processes and serve as a Subject Matter Expert, reviewer, or approver for controlled documents. Prepare detailed reports summarizing study results and their conformance to acceptance criteria while establishing project timelines, deliverables, and accountability for program budgets. This fully remote role reports directly to the Director of Technical Services, supporting clients in bringing life-saving therapies to patients faster across pharmaceutical, biotechnology, and medical device sectors.
Required Qualifications
- 10+ years as Principal or Sr. Principal system engineer, technical lead, or equivalent experience in the development of combination products and/or medical devices
- BS in Engineering, Biology, Physics or related Scientific discipline
- Technical management of programs in both direct or matrix reporting organizations, coordinating and leading multiple team members through the execution of program deliverables
- Experience with the total lifecycle management of medical device programs
- Direct experience developing design history file documentation in quality management systems, including Design and Development Plans User needs Requirements Risk management Verification Validation Design Transfer
- Experienced in leading technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems
- Thorough understanding of medical device processes: Design Controls (21 CFR 820.30) ISO13485 ISO14971
- Experience with, as well as experience and flexibility to work under a number of different quality management systems
- Experience supporting regulatory teams in the authoring of regulatory submissions
- Experience with project management
- Experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems
Desired Qualifications
- Master's degree in Engineering, Biology, Physics or related Scientific discipline
- Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems
- Understanding of DHF elements, and their integration through the medical device development process
- Preferred SOP Writing and Review
- Highly preferred, Experience with project management
- Preferred, experience supporting regulatory teams in the authoring of regulatory submissions
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