Note: The job is a remote job and is open to candidates in USA. BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services. The Principal Consultant will lead technical discussions and manage projects in the development of drug delivery systems, ensuring compliance with industry standards and regulatory requirements.
Responsibilities
- Leading technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems
- Align program execution with industry standards, external regulatory requirements and site quality management systems
- Development of design control deliverables to document compliance to medical device development processes
- May help as Subject Matter Expert (SME), reviewer, or approver of controlled documents within area(s) in of competency
- Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria
- Establish and maintain project timelines and deliverables and maintain accountability for project budgets and program execution
- Align program execution with industry standards, external regulatory requirements and site quality management systems
- Development of design control deliverables to document compliance to medical device development processes
- May help as Subject Matter Expert (SME), reviewer, or approver of controlled documents within area(s) in of competency
- Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria
- Establish and maintain project timelines and deliverables and maintain accountability for project budgets and program execution
- Apply the application of standards and regulatory requirements to the development of medical devices
Skills
- 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
- 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
- Understanding of DHF elements, and their integration through the medical device development process
- Thorough understanding of medical device processes: Design Controls (21 CFR 820.30), ISO13485, ISO14971
- Master's degree in Engineering, Biology, Physics or related Scientific discipline is desired
- Preferred experience in the clinical and commercial development of drug delivery systems (combination products)
- Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems
- Preferred SOP Writing and Review Experience with, as well as experience and flexibility to work under a number of different quality management systems
- Preferred, experience supporting regulatory teams in the authoring of regulatory submissions
- Highly preferred, Experience with project management
- Experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems is a plus
Benefits
- Fully remote consultancy
- Work from your home office
Company Overview