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Quality Assurance Specialist Principal

Date: Jan 6, 2022

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 51675 
Title: Quality Assurance Specialist Principal 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

 

 

 

 

 

 

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Quality Assurance Specialist Principal focused on Good Clinical Practices who will work  directly with the Quality, Compliance, and Risk Management departments within Arthrex to advance the Arthrex Mission of “Helping Surgeons Treat Their Patients Better” by creating and maintaining a dedicated function to assure the Quality, Compliance, and Risk Management of Arthrex Clinical activities. We need a proven quality expert relative to Clinical regulatory requirements in the Medical Device space.  A leader and influencer who will combine a thorough knowledge of applicable regulations and standards for Good Clinical Practices with a keen understanding of process and risk for the creation of a successful framework supporting multi-phase evaluations of Arthrex products globally.  Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Understands, successfully navigates, and communicates the Clinical Regulatory landscape of multiple regions as applicable to Medical Devices, Biologic products, and medical consumables as applicable.
    • US FDA Code of Federal Regulations (CFR)
      • 21 CFR 11 – Electronic Records & Signatures
      • 21 CFR 50 – Protection of Human Subjects
      • 21 CFR 54 – Financial Disclosure
      • 21 CFR 56 – Institutional Review Boards
      • 21 CFR 812 – Investigational Device Exemptions
      • 21 CFR 814 – Premarket Approval of Medical Devices
    • (EU) 2017/745  “EU MDR”
      • Clinical Evaluation
    • International Conference on Harmonization (ICH) - Unified standard for the EU, Japan, USA, Canada, Switzerland
      • E2A - Clinical Safety Data Management
      • E3 - Clinical Study Reporting
      • E6 - Good Clinical Practice Integrated Addendum (E6R2)
      • E7 - Geriatric Populations
      • E8 - General Considerations for Clinical Trials
      • E9 - Statistical Principles
      • E11 - Pediatric Populations
    • International Standards Organization (ISO)
      • 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice
      • 13485:2016 – Medical Devices Quality Management Systems
      • 14971:2019 - Application of Risk Management to Medical Devices
    • Other Industry-Specific Standards (e.g., 10993)
  • Maps current processes, Reviews existing GXP documentation, Creates and implements plans for gap closure.
  • Collaborates on educational initiatives to develop GCP content and train Arthrex personnel.
  • Reviews study protocols where appropriate.  Compiles and distributes information supporting GCP impact for prospective, ongoing, and completed studies as they relate to the Regulatory Status of Arthrex Product.
  • Audits prospective CROs for Supplier Qualification as appropriate.
  • Liaises with Regulatory Affairs and Quality in-country partners to assess risk and support development of OUS programs.
  • Verifies and keeps metrics related to effectiveness of completed changes and risk mitigation activities and supports remediation activities as appropriate.
  • Communicates effectively with internal and external business partners, including Orthopedic Research, Regulatory Affairs, Product Management, Engineering, Quality, IT, and other functions as appropriate to achieve company objectives.  Professionally communicates critical time-sensitive information, exceptions, and changes to affected parties.
  • Supports Regulatory audits and inspections as applicable.

 

This is an in-office position located in Naples, Florida; it is not a remote position.

 

Education and Experience:

  • Bachelor’s degree required.
  • 10 years of experience in a Clinical Quality, Regulatory, or Clinical-adjacent role within the regulated industry (Medical Device, Pharma, or Biotech) required.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Working knowledge of applicable Regulations and Standards
  • Ability to operationalize (communicate, engage, implement) Regulatory requirements.
  • Ability to navigate internally and externally across levels. 
  • Strong integrity and commitment. 
  • Ability to assess, plan, schedule, and manage complex projects in a dynamic environment. 
  • Collaborative, positive approach.

 

 

 

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


Nearest Major Market: Naples

Job Segment: Geriatric, Medical, Orthopedic, Engineer, Quality, Healthcare, Engineering