We offer integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging our deep scientific, medical, and regulatory expertise and real-world experience. Our goal is to help you complete projects efficiently and with less risk, leading to solutions for a healthier and safer world.
With a broad range of renowned scientific, medical, regulatory, and engineering specialists under one roof, we streamline your project and reduce your workload, so you can make sound, science-based decisions about human and environmental health issues.
BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. Across these specialized areas, we collaborate to deliver science-driven solutions that support industries including pharmaceuticals, biotechnology, medical devices, chemicals, foods and consumer products. Our collective expertise helps clients navigate regulatory requirements, assess safety and efficacy, manage risks, and optimize pharmaceutical commercialization strategies.
If you’re ready to achieve your life science goals, there’s no better partner than BlueRidge Life Sciences.
Job Description:
We are Suttons Creek, LLC We are a fully remote consultancy that supports the medical device, pharmaceutical, and biotechnology industries in bringing life-saving therapies to patients faster. We work with companies all over the world and are looking for highly motivated people that want to contribute to making an impact in peoples’ lives.
ABOUT YOU:
You're ambitious, detail-oriented, and quite frankly, you get stuff done. You don’t need to be told what to do because you can look around, see what needs to be done, and do it. You want to be exposed to all facets of a company, and you have what it takes to drive everything from small, administrative tasks, to large, business critical projects. You love to learn, you have a strong work ethic, and you've never said the words, "that's not my job." You're relentlessly optimistic, and you bring "good energy" everywhere you go. You thrive in fast paced, highly entrepreneurial environments.
SOME OF THE THINGS YOU'LL DO:
We are actively seeking team members who can serve as critical members of our Technical Services Team in delivering solutions for our client base. In this role you will participate in the project management and technical work of combination product development and the nuances of this complex regulatory environment as you support out client’s in bringing live-saving therapies to patients. You will report directly to the Director, Technical Service and take direction from him/her on client-related projects. Desired candidates will have a breadth of exposure defined by the following experience:
The Senior Systems Engineer will report directly to our Director of Technical Services and take direction from him/her on client-related projects.
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
Provide drug delivery and combination product consulting services as a Suttons Creek team member in areas related to Regulatory and Quality projects as assigned.
- Developing Regulatory and Quality strategies and executing upon those strategies for drug delivery and combination product companies.
- Stay abreast of current industry trends and changes and communicate those to internal Suttons Creek staff and clients
- Support the Suttons Creek Clients with project management, technical work and supportive services for assigned projects
- Support with the development of regulatory, quality and engineering business templates, protocols and service offerings for Suttons Creek
- Support with identifying and development of new profit centers and client offerings
- Support with the identification of potential Suttons Creek consulting talent through regulatory, quality and industry connections
- Support with the Suttons Creek Internal Quality Management System to govern our client deliverables as a company
- Support with developing a strong internal team culture at Suttons Creek
- Remote-based with 20-30% domestic/international travel
Qualification and Experience:
The essential functions include, but are not limited to the following:
4+ years of Regulatory or Quality experience related to pharmaceutical-related medical devices, combination products and/or drug delivery systems.
- Bachelor’s degree in Engineering, Biology, Physics or related Scientific discipline, or equivalent experience
- Preferred: Master’s degree in Engineering, Biology, Physics or related Scientific discipline
- Exposure to pharmaceutical-related medical devices, combination products and/or drug delivery systems.
- Preferred: Direct experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems.
- Understanding of Design History File elements, and their integration through the medical device development process.
- Understanding of the Design Control process for medical device development and application of ISO 14971 Risk Management principles.
- Knowledge and experience authoring and compiling US/EU regulatory submissions for drugs and/or devices ( e.g. NDA, BLA, IND, PMA, 510k, IDE, MAA, CE Mark, NB opinion, Meeting Requests).
- Strong written and oral communication skills
- Problem solving and critical thinking skills.
- Project management skills and knowledge of current project management tools and concepts.
Physical Demands and Work Environment
Office Environment: This role is fully remote and you will work from your home office. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions
