Independent Consultant

November 4

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Suttons Creek, Inc.

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Medical Devices • Remediation • Combination Products • Pharmaceuticals • Connectivity

11 - 50

Description

• We are Suttons Creek, 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 specifically in the development and successful launch of combination products (drug and device). • You're a professional consultant who is detail-oriented, works well with clients of different sizes and goals and quite frankly, you get stuff done. • You thrive in fast paced, highly entrepreneurial environments.

Requirements

• 5+ years as an independent consultant working with drug, biologics or device companies. • Your overall work experience should be in excess of 10 years with a variety of experiences related to drug/device combination experience in guiding and influencing their Human Factors, Quality or Regulatory Strategies. • BS in Engineering, Biology, Physics or related Scientific discipline, or equivalent experience • Preferred: Master’s degree in Engineering, Biology, Physics or related Scientific discipline is desired. • Demonstrated expertise in Pharmaceutical-related medical device experience on combination products and/or drug delivery systems. • Strong understanding of DHF elements, and their integration through the medical device development process. • Understanding of medical device processes including: Design Controls (21 CFR 820.30) • Demonstrated experience as a program or project lead