Ken Block Consulting is an international medical device regulatory and quality system consulting organization, with offices located on three continents and within major metropolitan areas (Dallas, Tokyo, Paris). We provide both on-site and off-site consulting services to clients ranging from small startups to large multi-national corporations, helping clients achieve international regulatory compliance and new device market entry success. As a member of our team, you will have the opportunity to help our many clients surmount many kinds of regulatory and quality-related challenges. In the process, you will also gain valuable experience and knowledge in the ever-changing regulatory and manufacturing landscapes. Since we have offices on three continents and clients all around the world, ample travel opportunities are available to those who are interested, in addition to the chance to represent KBC at international events.
KBC offers a competitive set of benefits, including full health/dental/vision insurance as well as a matching 401(k).
How to apply:
Please submit your resume in PDF format via email to firstname.lastname@example.org, noting the position you are applying for in the subject line.
Developing appropriate regulatory strategy for new medical devices, creating high-quality FDA submissions for new and modified devices, evaluating 510(k) necessity for device changes, following regulatory guidance documents to determine device verification & validation requirements, writing client & company procedures, and other duties as required.
Prior medical device experience including experience with 510(k) applications, FDA & ISO 13485 quality system compliance, procedure & protocol development, etc. Excellent writing skills, ability to succinctly summarize complex concepts & systems, efficient communication skills, self-motivation, effective time management, etc. Availability & willingness to travel domestically and internationally.