Scott P.

Regulatory Affairs | Quality Management | MedTech

United States of America
EN

Professional with 13+ years of experience in the MedTech industry. Specializes in Regulatory Affairs and Quality Management.

  • Biotechnology & Life Sciences
  • Pharmaceutical

400

/hr
  • Pre-vetted expert
  • Confirmed hourly rate
  • Available on short notice

Experience

Vice President, Quality and Regulatory Affairs

OtoNexus Medical Technologies
2 years
Current position
Sep 2020 - Present
Responsible for quality and regulatory affairs strategy development and execution that will help a start-up medical device company bring a novel technology to market. OtoNexus is deve...see more

Sr. Director Regulatory Affairs and Quality Systems, Compliance Officer

FUJIFILM Sonosite, Inc.
6 years
May 2014 - Aug 2020
Regulatory Affairs and Quality Systems - Head of FUJIFILM SonoSite regulatory affairs and quality systems while reporting to the company President - Direct domestic and international re...see more

Sr. Manager Regulatory Affairs

FUJIFILM SonoSite, Inc.
1 year
Feb 2013 - May 2014
Led a team responsible for all FUJIFILM SonoSite domestic and international regulatory product submissions/registrations, along with pre-market regulatory planning and new regulation gu...see more

Sr. Regulatory Affairs Specialist

FUJIFILM SonoSite, Inc.
1 year
Sep 2011 - Feb 2013
Domestic and international regulatory submissions for class II medical devices. FDA 510(k), Japanese STED, Health Canada, EU. Works with other international offices and distributors t...see more

Regulatory Affairs Specialist

SonoSite, Inc.
2 years
Nov 2009 - Sep 2011
Focused on regulatory compliance of SonoSite's quality system. Complaints, CAPA, and internal auditing.

Quality Systems Specialist

Spencer Technologies (Spentech Inc.)
1 year
Jul 2008 - Nov 2009
Provided quality assurance and regulatory affairs support. Was involved with maintenance and improvement of a quality system compliant with ISO 13485, MDD, CMDR and FDA QSRs.

Research Scientist/Engineer

University of Washington
6 years
Sep 2002 - Jul 2008
The University of Washington is a public university in Seattle , Washington , United States . The university was founded in 1861. It is the largest university in the Northwestern United...see more

Industries, roles and expertise

Industry experience

  • Biotechnology & Life Sciences
  • Pharmaceutical

Expertise

  • ISO
  • Quality Assurance
  • Quality Management
  • CAPA
  • FDA
  • Product Launching
  • FDA GMP
  • Product Development
  • Regulatory Affairs