Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 300 /hr

★★★★★

☆☆☆☆☆

Hire Peter O.

United States

USD 300 /hr

Experienced quality assurance and regulatory affairs professional in the medical device industry.

Profile Summary

Product experience includes Class 1, 2 and 3 devices: external defibrillators, AEDs, infusion pumps, patient monitors, image guidance, ventilators, medical device software, clinical informatics, diagnostic ECG, medical consumables and supplies, contact lenses and solutions, angiographic catheters. Proven leadership in multi-site, global organizations as well as start-up and post IPO organizations. Ability to navigate the FDA at all levels and work with the agency on a wide variety of issues, including: FDA inspection management, response and remediation, warning letter remediation, product clearance, investigational devices and recall management.

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ★ Product Compliance
• ★ Regulatory Writing
• ☆ Medical Devices
• ☆ European Medical Device Regulation (MDR)
• ☆ Diagnostic Radiology
• ☆ Investigational Device Exemption (IDE)

Services

• Writing
• Consulting

Writing Technical Writing

Consulting Scientific and Technical Consulting

Work Experience

Principal

NorthShore Quality and Regulatory Solutions LLC

May 2015 - Present

Principal Consultant

Halloran Consulting Group

September 2015 - January 2018

Vice President Quality and Regulatory

Philips Healthcare

September 2010 - August 2014

Senior Director Quality and Regulatory

Philips Healthcare

January 2006 - September 2011

Director Quality and Regulatory

Philips Healthcare

August 2001 - January 2006

Visualization Technology

Vice President Quality and Regulatory

August 1998 - September 2001

Vice President Quality and Regulatory

ZOLL Medical

July 1993 - August 1998

Education

MS Engineering Management

Northeastern University

January 1983 - January 1989

BS Biology

Boston College

September 1974 - May 1978

Certifications

• Certification details not provided.