Summary
Overview
Work History
Education
Skills
Certification
RESTAURANT EXPERIENCE
Timeline
Generic

Jamie Bradshaw

Woodstock,GA

Summary

Experienced quality, document control and regulatory compliance professional with a solid track record of maintaining compliant Quality Management Systems (QMS). Proven ability to develop, implement, and maintain QMS, Document Control and compliance systems, drive continuous improvement, and ensure adherence to regulations and standards. Adept at leading audits, managing corrective actions, and collaborating with suppliers. Expertise in risk management, manufacturing safety, training, process optimization and improvement, and customer satisfaction. Actively seeking new opportunities where I can leverage my current skills and contribute to a company's success by ensuring product/service quality and safety, regulatory/industry compliance, customer satisfaction, compliant document management systems and successful business outcomes.

Regulatory professional known for high standards and results-driven approach. Proven ability to navigate complex regulatory environments and implement effective compliance strategies. Committed to fostering team collaboration and adapting to evolving regulatory requirements. Skilled in regulatory research and compliance monitoring, valued for reliability and flexibility.

Overview

27
27
years of professional experience
1
1
Certification

Work History

Principal Lifecycle Regulatory Specialist

Exactech, Inc.
09.2022 - Current
  • Delivered expert guidance throughout the product lifecycle, supporting the successful commercialization and ongoing management of products and services.
  • Prepare management certification applications to state and federal regulatory agencies.
  • Assessed proposed changes to evaluate potential risk impact, ensuring compliance with applicable requirements and standards.
  • Developed and executed strategies for product maintenance, improvement, and market access to support business objectives.
  • Managed renewal processes efficiently, ensuring timely submission and approval of all necessary documentation to maintain product compliance and market continuity.
  • Led global regulatory strategy and compliance efforts for a diverse portfolio of medical devices, influencing safety and data privacy standards, and providing input on company product goals.
  • Developed, documented, and deployed comprehensive global policies and procedures, streamlining operations and ensuring alignment with international standards and regulatory requirements.

Sr. Regulatory Engineer

Philips Respironics
08.2019 - 09.2022
  • Led regulatory compliance efforts, ensuring adherence to relevant regulations and standards.
  • Supported the development and ongoing maintenance of new products and services.
  • Verified that labeling and documentation complied with regulatory and internal requirements.
  • Prepared and maintained submission packages, including technical documentation and testing data.
  • Managed product end-of-life processes, ensuring compliance and promoting responsible disposal or recycling practices.
  • Collaborated with R&D teams on new product development, providing regulatory expertise to facilitate smooth integration.
  • Improved efficiency of Engineering Change Request (ECR) processes, including document control and issue resolution, to ensure timely implementation.
  • Provide technical guidance both internally and externally.
  • Monitor regulatory developments and changes. Implement and communicate changes within company QMS and policies as necessary.

Regulatory Consultant

ALKU/Philips Respironics
04.2019 - 08.2019
  • Offered expert guidance on regulatory compliance for assigned projects, ensuring adherence to applicable standards and requirements.
  • Developed and implemented strategies and plans, including regulatory submissions and post-market surveillance activities.
  • Utilized data collection and analysis tools to monitor compliance and evaluate supplier performance.

Senior Quality Specialist

Visioneering
12.2018 - 04.2019
  • Managed documentation and record-keeping processes, ensuring accuracy and consistency across all files and workflows.
  • Coordinated audit preparations and supported process improvement initiatives to enhance operational efficiency.
  • Handled customer inquiries and feedback, ensuring timely resolution and maintaining high satisfaction standards.
  • Maintained and streamlined document workflows, improving accessibility and organizational efficiency.

Quality Manager

Secure BioMed Evaluations
04.2018 - 11.2018
  • Led performance management and professional development for a team of six direct reports, including quality engineers and technicians, fostering a high-performance work environment.
  • Acted as the quality manager for multiple clients, supporting the implementation and continuous improvement of compliant Quality Management Systems.
  • Developed and facilitated ISO and FDA training programs to ensure employee competency, regulatory awareness, and adherence to quality standards.
  • Designed and implemented Quality Management Systems for startup companies, ensuring compliance with customer specifications, industry standards, and regulatory requirements.
  • Led the quality department for start-up organizations, overseeing document control systems, Customer Compliant Handling, Supplier Control, Corrective and Preventive Actions and ensuring organizational adherence to quality best practices.
  • Trained team members in GMP, GDP, and risk assessment methodologies such as FMEA and hazard analysis to support robust risk mitigation and compliance efforts.

Regulatory Affairs / Post Market Quality Specialist

Mölnlycke Health Care
08.2014 - 04.2018
  • Managed comprehensive regulatory activities across Latin America, including Brazil, Colombia, Panama, Mexico, Peru, Ecuador, Puerto Rico, and Bolivia, ensuring compliance with local post-marketing requirements and international reporting standards.
  • Led product registration and dossier preparation efforts, and implemented a promotional advertising review system to maintain regulatory compliance and support effective communication with customers and stakeholders.
  • Conducted detailed post-market surveillance activities, including trend analysis of adverse event data, to identify and mitigate potential safety signals, ensuring timely communication with customers and regulatory bodies.
  • Oversaw ongoing product performance monitoring, analyzed customer feedback, and performed risk assessments to proactively address safety and quality concerns, enhancing customer satisfaction and trust.
  • Maintained in-depth expertise in MDR reporting, vigilance reporting, and field corrective actions, including recalls and product withdrawals, ensuring prompt and compliant responses to customer and regulatory inquiries.
  • Lead incident investigations, Create action plans, generate, prepare and write incident reports.

Regulatory Affairs Specialist II/Quality Control

Dornier Med Tech America Inc.
08.2005 - 03.2014
  • Acted as a liaison between the European parent organization and global affiliates, coordinating information necessary for submissions and ensuring adherence to all regulatory requirements.
  • Developed and delivered training programs on FDA, ISO, OSHA, and QSR standards, ensuring employee competency, regulatory compliance, and quality awareness across teams.
  • Implemented quality control inspections and testing protocols for incoming materials, in-process components, and finished products to verify compliance with established quality standards.
  • Identify and close ongoing gaps in Quality Management System.
  • Managed a comprehensive supplier audit program and maintained detailed supplier documentation for material suppliers and contract manufacturers, ensuring compliance with quality agreements and regulatory obligations.

Documentation Associate/Administrative Coordinator/Safety Specialist

CryoLife, Inc.
10.2000 - 08.2005
  • Ensure the adequate control, formatting, tracking, and continued maintenance and timely generation of documents included in the Document Control Program to ensure compliance with both internal procedures and external regulatory requirements.
  • Assist facility operations staff in the daily administration of various functions within the department, including administration of the Safety Plan, administration of the MSDS system, administration of inventories, tracking purchase requisitions, and other related documents to parts and supplies.
  • Organize, schedule, monitor, and coordinate training activities for all employees to CFR Rule 29 Part 1910 and part 1926. Training including Personal Protective Equipment (PPE), Hazardous Materials, Occupational Health and Environmental Control, Fire Protection, Lockout/Tagout, General Office Safety, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP).
  • Prepare Budgets, personnel schedules, plans and schedules meetings and events.
  • Maintains calendar of appointments and travel arrangements.
  • Skills: Expertise in root cause analysis, CAPA (Corrective and Preventive Action), regulatory submissions (510(k), PMA, IDE), risk assessments (FMEA, HAZOP), change control, document management, and process validation (IQ/OQ/PQ).

Office Manager / Document Control

Carlton Rakestraw & Associates (CRA) Land Surveying Office
05.1998 - 10.2000
  • Performing basic plat research, managing records, using computer-aided design (CAD) software, and assisting with data processing.
  • Responsible for general office duties, such as filing, data entry, Accounts Payable/Receivable/Document Management.
  • Work with engineers, architects, construction teams and government agencies on projects.
  • Create, maintain and file legal documents for land surveys.
  • Maintain documentation required for Engineering Change Requests.

Education

Bachelor's Degree - Project Management

Capella University

Skills

  • FDA 21 CFR 820
  • Adobe Pro
  • Environmental Management Systems (EMS)
  • Adverse Event Reporting (MDR, Vigilance, etc)
  • Corrective Action/Preventive Action (CAPA)
  • Change Management
  • Compliance
  • Compliant Management
  • CRM Systems
  • Data Analysis
  • Database Management
  • Design and Development
  • Design Controls
  • EU MDD/MDR
  • FDA Audits
  • FDA Regulations & Guidance Documents
  • FMEA
  • GAP Assessments
  • Greenlight Guru
  • Hazard Analysis
  • ISO 9001
  • ISO 10993
  • ISO 11607
  • ISO 13485
  • ISO 14971
  • ISO 14001
  • MDSAP
  • Medical Device Sustaining Tasks
  • Microsoft Access Database
  • Microsoft Office Suite
  • Microsoft Visio
  • Pivot Tables
  • Post Market Surveillance
  • Premarket notification
  • Procedure Writing
  • Product Development
  • Project Management
  • Quality Management System (QMS)
  • REACH / ROHS / TSCA / WEEE / Prop 65 / ISO
  • Regulatory Strategy
  • Risk Management
  • Trending Analysis
  • Root Cause Analysis
  • SAP
  • SCAR
  • Sharepoint
  • Supply Chain Management
  • Training
  • Change Control
  • Engineering Change Requests
  • Supplier Change Requests
  • Document Workflows
  • OSHA
  • Hazardous Material Safety
  • GCP/GDP
  • SQL
  • ALCOA
  • Scheduling
  • Filing
  • Customer Service
  • HIPAA
  • Strategic Planning
  • Stakeholder Change
  • Risk
  • Policy/Procedure Data
  • Management
  • Management Enforcement
  • Assessments
  • Development
  • Management & Protection
  • Veeva
  • Master Control
  • Team Center
  • Mondaycom
  • Basecamp
  • Quickbooks
  • Transportation regulations
  • Food safety regulations
  • Labeling compliance
  • Hazard communication
  • Legal research
  • Medical device regulations
  • Documentation review
  • Occupational safety
  • Environmental monitoring
  • Regulatory reporting
  • Global regulatory compliance
  • Regulatory submissions
  • Biotechnology regulation
  • Regulatory policies
  • Project management
  • Tableau
  • Risk management
  • Audits
  • ISO standards
  • Inspections
  • Document control
  • Technical documentation
  • FDA regulations
  • Forms management
  • Time management
  • Leadership skills

Certification

ISO 13485 Lead Auditor Certification

RESTAURANT EXPERIENCE

  • Taco Mac – Server / Bartender
  • Briar Patch – Server
  • Fletchers – Server
  • Chick Fil A – Assistant Manager

Timeline

Principal Lifecycle Regulatory Specialist

Exactech, Inc.
09.2022 - Current

Sr. Regulatory Engineer

Philips Respironics
08.2019 - 09.2022

Regulatory Consultant

ALKU/Philips Respironics
04.2019 - 08.2019

Senior Quality Specialist

Visioneering
12.2018 - 04.2019

Quality Manager

Secure BioMed Evaluations
04.2018 - 11.2018

Regulatory Affairs / Post Market Quality Specialist

Mölnlycke Health Care
08.2014 - 04.2018

Regulatory Affairs Specialist II/Quality Control

Dornier Med Tech America Inc.
08.2005 - 03.2014

Documentation Associate/Administrative Coordinator/Safety Specialist

CryoLife, Inc.
10.2000 - 08.2005

Office Manager / Document Control

Carlton Rakestraw & Associates (CRA) Land Surveying Office
05.1998 - 10.2000

Bachelor's Degree - Project Management

Capella University

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Jamie Bradshaw