Frank Peralta

Sr. International Regulatory Affairs Specialist at Stryker Neurovascular

Location
San Francisco Bay Area
Industry
Medical Devices

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Frank Peralta's Overview

Current
Past
  • Sr. Regulatory Affairs Specialist at Maquet Cardiovascular
  • Partner, Regulatory Affairs at Ascenso Health
  • Sr. Regulatory Affairs Specialist at LifeScan
  • Regulatory Affairs Associate at Guidant/Endovascular Technologies
  • Regulatory Compliance Management at St. Jude Medical (Ventritex)
  • QA various at Collagen Corp. (aka McGhan/Inamed, Allergan)
  • Account Executive (part-time) at Baraban Securities
  • Founding Member at GMP Trainers Group
  • Quality Assurance/Manufacturing various at Cutter-Miles Laboratories (Bayer AG)
  • QA Product Administrator at Bayer, Berkeley, CA
Education
Connections

371 connections

Frank Peralta's Experience

Sr. International Regulatory Affairs Specialist

Stryker Neurovascular

Public Company; 10,001+ employees; SYK; Medical Devices industry

April 2012Present (2 years 6 months) Fremont, CA

Sr. Regulatory Affairs Specialist

Maquet Cardiovascular

Privately Held; 5001-10,000 employees; Medical Devices industry

February 2010April 2012 (2 years 3 months)

Partner, Regulatory Affairs

Ascenso Health

October 2009November 2011 (2 years 2 months)

Ascenso Health is a multi-national company based in the Silicon Valley, with field offices in Milan and Argentina, as well as sales branches around the world.

We are a dominant force in the field of real-time distance acquisition of human biometrics in areas as diverse as patient critical-care, Formula One race driver performance, and drug trials.

Founded in 2009 as an alliance between several existing companies, we formally merged in 2010. Our company is young with great vitality; the history of our product and our market spans the previous decade. With over 6000 devices placed around the world at several hundred locations, we have improved the lives of tens of thousands of people both in and out of care facilities.

Our current medical device product enables the portable capture and wireless transmission of continuous or intermittent health parameters via the cloud computing paradigm.

Sr. Regulatory Affairs Specialist

LifeScan

Public Company; 1001-5000 employees; JNJ; Medical Devices industry

November 2000October 2009 (9 years)

Project management, technical writing, preparation of premarket applications submitted to Food and Drug Administration, preparation of CE Technical Files, and preparation of foreign country product registrations. Special emphasis on preparation of 510(k)s for medical device software.

Regulatory Affairs Associate

Guidant/Endovascular Technologies

Public Company; 10,001+ employees; BSX; Medical Devices industry

19982000 (2 years)

Responsible for coordination and preparation of regulatory submissions including IDEs, IDE supplements, annual reports, 510(k)s, PMA supplements and international dossiers. Acts as internal consultant on regulatory issues and filing strategies. Represent Regulatory Affairs on product development teams; collaborate with engineering in development of preclinical test protocols, and in determination of appropriate data to support submissions. Responsible for international regulatory activities including foreign registrations and compliance with EC directives relating to medical devices. Directly responsible for writing departmental procedures to address RA issues.

Regulatory Compliance Management

St. Jude Medical (Ventritex)

19971998 (1 year)

Supervise daily compliance activities, including device history record review, packaging and labeling activities. Perform internal quality system audits, function as lead auditor, write audit reports, provide follow-up of corrective action effectiveness. Active member of corrective action review board, regular contributor and presenter at quarterly management review. Participated in FDA and ISO audits as member of escort team.

QA various

Collagen Corp. (aka McGhan/Inamed, Allergan)

19831996 (13 years)

Account Executive (part-time)

Baraban Securities

March 1988September 1991 (3 years 7 months)

Series 7, NASD licensed.

Founding Member

GMP Trainers Group

19851988 (3 years)

Quality Assurance/Manufacturing various

Cutter-Miles Laboratories (Bayer AG)

19741982 (8 years)

QA Product Administrator

Bayer, Berkeley, CA

19741982 (8 years)

Frank Peralta's Skills & Expertise

  1. Regulatory Affairs
  2. 510 K
  3. Regulatory Submissions

Frank Peralta's Education

Lincoln Law School of San Jose

Law

19951996

College for Financial Planning

Masters Program, Financial Planning (Estate Planning emphasis)

19911992

College for Financial Planning

Certificate, Personal Financial Planning

19891991

University of California, Berkeley

A.B., Biochemistry

19711973

Frank Peralta's Additional Information

Interests:

Electric & Acoustic Guitar, 6-string and 4-string electric bass. Performance Experience: played lead/rhythm, semi-professionally with several cover bands. Style of Play: R&B, Blues, Smooth Jazz, Funk, Classic Rock Formal Music Education: Joe Bruhl Guitar School, Steve Erquiaga; Workshops/Clinics/Lessons: Stanford Jazz Workshop; Pat Martino; Robben Ford; Tommy Emmanuel; Berklee School of Music (Boston); Vinny Valentino (currently). California Jazz Conservatory (formerly The Jazzschool), Berkeley, CA (currently)

Groups and Associations:

Regulatory Affairs Professionals Society, California Alumni Association

Honors and Awards:

Johnson & Johnson Process Excellence, Green Belt Certified

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