We are Suttons Creek, L LC. 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.

We are actively seeking a team member  who can serve as critical members of our Regulatory, Technical Services Team in delivering solutions for our client base. In this role you will lead 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 Services and take direction from him/her on client-related projects. Desired candidates will have a breadth of exposure defined by the following experience:

Position Summary 

In this role our expectations are as follows: 

• Provide drug delivery and combination product consulting services as a Suttons Creek team member in areas related to Regulatory and Quality projects as assigned.
• Leads teams of assembled consultants to execute on client projects 
• Develop Regulatory and Quality strategies and execute 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 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 Sales Cycle and client procurement 
• Develops our junior consultants and foster relationships with consultants in unique fields of specialty 
• Support with developing a strong internal team culture at Suttons Creek
•  Remote-based with 20-30% domestic/international travel

Minimum Qualifications (Knowledge, Skills, and Abilities)

• 7+ years of Regulatory experience with a focus on pharmaceutical-related combination products and/or drug delivery systems
• BS in Engineering, Biology, Chemistry, Physics or related Scientific discipline, or equivalent experience 
• Demonstrated expertise in Pharmaceutical-related medical devices, combination products and/or drug delivery systems- with experience in development and life-cycle management.
• Strong understanding of DHF elements, and their integration through the medical device development process.
• Understanding of medical device regulations, guidance, and standards
• Demonstrated project management skills and leadership abilities. 
• Preferred: Direct experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems.
• 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: 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.

**We offer a full slate of benefits including Medical and Dental insurance, PTO, 401k, etc.