Summary
Overview
Work History
Education
Skills
Projects
Timeline
BusinessDevelopmentManager
John Nelson

John Nelson

Regulatory Affairs
Winter Garden,USA

Summary

Seasoned Regulatory Affairs Officer and leader with four years in developing effective processes and executing regulatory affairs initiatives for Medical Device industry. Partnered with GWU to improve processes and assist product development in meeting regulatory requirements, such as establishing registration, medical device listing Premarket Notification 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Quality System Regulations (QS regulation), Labeling, and Reporting. Maintained and followed up on records of regulatory information and submissions.


Rational cryptologic leader with four years of experience enhancing operations for organizations through information systems solutions. Proven track record of transforming specific business goals related to growth and efficiency improvements into new system designs. Knowledgeable innovator known for recommending new technologies to enhance existing systems and introduce new systems.


Results-driven Network Engineer with 10+ years of expertise deploying and maintaining LAN and WAN infrastructure. Dedicated technology professional with strong track record of accurately conducting system repairs and troubleshooting. Offering exemplary planning, project management and communication talents.


Motivated Biomedical Equipment Technician successful in providing biomedical equipment and device integration, inspection, maintenance and repairs.

Overview

26
26
years of professional experience
10
10
years of post-secondary education

Work History

Biomedical Equipment Technician

US Navy
01.2020 - Current
  • Maintained proper care and storage of 120+ different diagnostic tools and equipment and tracked inventory.
  • Provided validation, inspection, repairs and maintenance on over 450 clinical biomedical equipment.
  • Inspected, tested and calibrated 65 different medical equipment pieces before installing.
  • Developed 45 presentations and provided 24 on-site demonstrations of latest biomedical devices, technologies and procedures.

Hospital Corpsman

US Navy
06.2016 - Current
  • Provided emergency medical care, including conducting physical exams and interviews to gain medical history and relevant health data.
  • Administered medical care for range of conditions and basic health concerns including immunization, medications and blood draws.
  • Provided leadership, delegation and exceptional medical service in high-pressure situations.
  • Administered medical care for range of conditions and basic health concerns.
  • Provided emergency medical care and conducted physical exams and interviews to gain medical history and relevant health data.
  • Assisted 507 Marines in returning to full duty, cutting downtime and expenses.
  • Maintained treatment records and reports and cared for over 1200 injured and sick individuals per week.
  • Consolidated global information relevant to Medical Evacuation and monitored global submissions and approvals status.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Maintained historical reference by abstracting and coding clinical data such as diseases, operations, procedures and therapies with standard classification systems.
  • Obtained necessary signatures on information release forms to obtain medical and treatment records from other service providers.
  • Trained 42 direct reports on department procedures and policies to maximize department productivity.
  • Managed practical action plans to respond to audit discoveries and compliance violations.
  • Liaised with risk management, internal audit and employee services departments to direct compliance issues to appropriate channels for investigation and resolution.
  • Oversaw and monitored violation tracking system for accuracy, which reduced Medical Readiness issues by more than 6% in base of 5000+ members.

Mathematics Teacher

Lake County Public Schools
Clermont, FL
2009 - Current
  • Diversified teaching techniques and learning tools help 1750 students with differing ability levels and varied learning modalities.
  • Assessed 245,000 submitted class assignments, determined grades and reviewed work with struggling students to boost success chance to at least 70%.

Water Polo Official

USA Water Polo
Huntington Beach, CA
01.2010 - Current
  • Assisted in developing, teaching and instructing 14,500 student-athletes in proper rules of competition, techniques, life skills and leadership qualities.
  • Taught physical conditioning relative to sport.
  • Explained and taught regulations and rules to 12,000 players and coaches.
  • Trained 120 new officials through on-site and online activities.
  • Promoted good sportsmanship among ALL players.

Personal Training Manager

Lifestyle Family Fitness
Winter Garden, FL
11.2007 - 11.2008
  • Built strong relationships with 1050 members to promote health, wellness and available services.
  • Led 3000 individual and 225 group wellness seminars and educational programs.
  • Monitored, tracked and reported on 60 individuals progress with wellness plans.
  • Helped 60 clients set and achieve health and wellness goals.

Manager of Operations

Eckerd Youth Alternatives, Inc. - Camp E Kel Etu
Ocala, FL
02.2003 - 10.2007
  • Responded to injuries, accidents, and allegations of abuse and misconduct by following company policies and when appropriate, law enforcement.
  • Participated in community events and met with local leaders to develop recreational activities for residents.
  • Improved success of program by making proactive adjustments to operations.
  • Developed Disney Volunteer program from ground up, laying out framework and defining roles.
  • Set and oversaw yearly $1.5 million budget to cover 62000 hours of new programming.
  • Worked in matrix management environment with oversight of division level managers, operations, sales, finance, human resources, safety and compliance.
  • Devised processes to boost long-term business success and increase profit levels.

Education

MBA - Healthcare Administration And Regulatory Affairs

George Washington University
Washington, DC
09.2018 - Current

Associate of Science - Biomedical Engineering Technologies

Navy Medicine Education And Training Command
San Antonio, TX
01.2020 - 03.2021

Certificate - Health Administration

International Sports Science Association
Carpinteria, CA
01.2006 - 06.2006

Bachelor of Science - Communications

California State University - Chico
Chico, CA
01.1999 - 05.2001

Whitworth University
Spokane, WA
09.1996 - 01.1999

Hospital Corpsman Basic

Navy Medicine Education And Training Command
San Antonio, TX
08.2016 - 10.2016

Hartnell College
Salinas, CA
06.2000 - 07.2000

Skills

Medical Device Statutes and FDA Integration Understanding

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Projects

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Timeline

Biomedical Equipment Technician

US Navy
01.2020 - Current

Associate of Science - Biomedical Engineering Technologies

Navy Medicine Education And Training Command
01.2020 - 03.2021

MBA - Healthcare Administration And Regulatory Affairs

George Washington University
09.2018 - Current

Hospital Corpsman Basic

Navy Medicine Education And Training Command
08.2016 - 10.2016

Hospital Corpsman

US Navy
06.2016 - Current

Water Polo Official

USA Water Polo
01.2010 - Current

Personal Training Manager

Lifestyle Family Fitness
11.2007 - 11.2008

Certificate - Health Administration

International Sports Science Association
01.2006 - 06.2006

Manager of Operations

Eckerd Youth Alternatives, Inc. - Camp E Kel Etu
02.2003 - 10.2007

Hartnell College
06.2000 - 07.2000

Bachelor of Science - Communications

California State University - Chico
01.1999 - 05.2001

Whitworth University
09.1996 - 01.1999

Mathematics Teacher

Lake County Public Schools
2009 - Current
John NelsonRegulatory Affairs