Jeff S.

Chief Quality & Regulatory Officer @ Moon Surgical

About

Following 10+ years of Active Duty with the US Navy as a Lieutenant Commander and Aviator, I left the military for Corporate endeavors. Since then, I've been repeatedly asked to move to new challenges after "fixing"/improving the outcomes of the functions for which I've been responsible. I've had successes in Human Resources, Operations, Quality and Regulatory Affairs. I have a long, demonstrated track record of success in multiple arenas.

Country

United States

City

Portland

Industry

Medical Device

Skill

Medical Devices, FDA, ISO 13485, Quality System, Cross-functional Team Leadership, Healthcare, CAPA, Process Improvement, Validation, Quality Auditing, Regulatory Affairs, Quality Assurance, Quality Management, Orthopedic, V&V, Strategic Planning, Leadership, ISO 14971, Design Control, Commercialization

Experience

Chief Quality & Regulatory Officer

Moon Surgical

2025-4 - Present · 1 yr 6 mos

Senior Vice President, Quality (& Regulatory) - Diagnostics

Siemens Healthineers

2022-12 - 2025-3 · 2 yrs 4 mos

New York, United States

Responsible for oversight of global quality system implementation, compliance and regulatory strategy for CLS and SLS business lines.

Vice President Quality & Product Surveillance

Varian

2018-1 - 2022-12 · 5 yrs

Palo Alto, CA

Responsible for global design controls, post-market surveillance and quality systems.

Senior Director Regulatory Affairs & Post Market Surveillance

Varian

2013-7 - 2018-1 · 4 yrs 7 mos

Palo Alto, CA

Responsible for post-market surveillance and design controls for Oncology Systems.

Director, Post Market Surveillance

Stryker

2011-1 - 2013-7 · 2 yrs 7 mos

Responsible for design, training and implementation of new corporate global complaint handling system, delivered on time and under budget in addition to process and procedures for global field actions and shipping holds and CAPA.

Director, Regulatory Affairs & Quality Assurance & Compliance Officer

Stryker

2007-1 - 2010-12 · 4 yrs

Responsible for the world-wide approval and registration with appropriate government entity for sale of the $650M division's medical devices used in minimally invasive surgery.

Director, Logistics & Distribution

Stryker

2005-1 - 2006-12 · 2 yrs

Responsible for world-wide distribution of the $370M division's raw materials, trial units and medical products consisting of Medical Beds, Stretchers, Cots and Furniture

Director, Human Resources

Stryker

2004-3 - 2005-1 · 11 mos

Responsible for talent recruitment, development and retention of the $100M division's distribution team in Canada. This was a temporary assignment.

Manager, Human Resources

Stryker

2002-3 - 2004-3 · 2 yrs 1 mo

Responsible for talent recruitment, development and retention of the $60M division's sales and support team in US as well as providing guidance to Manf mgt in Germany.

Manager, Human Resources

Stryker

1999-11 - 2002-2 · 2 yrs 4 mos

Responsible for talent recruitment, development and retention of the $250M division's internal team in California.

Lieutenant Commander (O-4)

US Navy

1989-6 - 1999-11 · 10 yrs 6 mos

Unrestricted Naval Aviator (LAMPS Pilot), Veteran 1st Gulf War, Assistant Branch Manager, Officer Allocation - Bureau of Personnel, Personal Assistant to Assistant Secretary of Defense, Assistant Navigator CVN-69 USS Dwight D. Eisenhower.