Bill Righter Email & Phone Number

Portland, Or, Us

Portland, Or

Technical Consultant -Regulatory Affairs & Medical Device Engineering at Righter Consulting Group, LLC

Golden, Colorado, United States

Hillsboro Or

A consultant specializing in providing regulatory expertise for medical device designs crafted under both FDA’s 21 CFR Part 820.30 and ISO13485 compliant quality management systems, including risk management activities. Create regulatory strategies for companies and projects. Resolve pre-market clearance issues to smooth and minimize the path to market. Discussions with FDA reviewers on behalf of clients experiencing regulatory issues related to pre-market approvals.Experience Highlights• Wrote technical content for several successful 510k) submissions.• Experienced in leading client discussions held FDA during teleconferences and negotiation meetings.• Technical Design Consultant for 2nd & 3rd generation wearable cardiac devices for San Francisco company.• Wrote US regulatory strategy for three companies in the EU.• Developed & wrote complete device descriptions and substantial equivalencies for class I and class II devices.• Developed proprietary sensors for mobile healthcare and consumer products.

Greater Boston

• Led regulatory affairs consulting projects for FDA compliance in medical device design.• Ensured standards compliance in software design for medical instruments.• Collaborated with companies to navigate evolving FDA regulations and guidance changes.

San Francisco Bay Area

Continuation (part-time) as a consultant in October 2010 after a 3-year full-time engagement (below), I developed wireless Bluetooth solutions, formulated anti-microbial electrodes, provided software support on first-generation products, and participated in document reviews as the outside technical source for various DHF documents.

San Francisco Ca

Rhythm Technologies is a digital healthcare company that develops FDA-cleared solutions that integrate wearable biosensor technology, patient data, and analytics for Cardiology. Delivered results focused direction to cross functional project teams assembled from R&D, Engineering, Regulatory, Marketing, and Manufacturing. Managed five internal engineers, a project manager, and up to eight consultants and third party design firms. Translated business goals and objectives into advanced product development strategies, with a $1M - $2M budget per project. Maintained the startup pace and task focus, while rigorously addressing all areas of the quality governance framework: design history, regulatory compliance, and risk management. .• Developed a regulatory strategy that completed and received FDA clearance on three medical device programs within one year, and with just one 510(k) application. Followed by two clearances in the second year, enabling improved forecasted revenue growth of $4M by the end of the following fiscal year.• Accelerated market entry by one quarter via a creative FDA submission strategy.• Directed novel mobile device designs while driving engineered cost reductions, leading to a reduced BOM cost of 50%.

Portland, Oregon Metropolitan Area

Med-tech design projects for the following client companies: Lifewatch, Carestats, Instromedix, SportPsych, and iRhythm Technologies. Projects included the design of a variety of medical instruments, mobile devices, and smartphone apps.

Rosemont, Il

Lifewatch is a provider of remote diagnostic cardiac monitoring technologies and services. Held general Engineering management functions at Beaverton, OR office. Closed the Oregon operation and moved it to Chicago HQ. Migrated to management consulting role after company move. Did Legal work on IP protection of patented technologies. Analyzed product make-vs-buy decisions for growing the product offerings.

Beaverton, Oregon, United States

Ralin Medical was founded upon the identified need for simple yet effective patient cardiac monitoring devices for early arrhythmia detection. I managed the development programs and participated in the designs of six innovative medical instruments and accessories. Five patents were awarded with co-inventors. Responsible for building a QMS system, including policies and SOPs, design controls, documented history files.

University Of The State Of New York, Bachelor Of Science (B.S.) 1993, Computer Software

Bachelor Of Science 1991, Engineering

BS degree concentration in Electronics Engineering. MS studies in Systems Engineering & Machine Design. Grad studies in Management.