Customer Quality Regulatory Specialist III
Location:
West Chester , Pennsylvania
Posted:
January 12, 2017
Reference:
3702161213-en-us

DePuy Synthes, a Johnson & Johnson company is hiring a Customer Quality Regulatory Specialist III that can be located in West Chester, PA.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

 

OVERALL RESPONSIBILITIES:

Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.

 
DUTIES:
  • Responsible and accountable for on-time submission and accuracy of regulatory reports
  • Prepare and submit Medical Device Report and/or Vigilance Report
  • Knowledge of and familiarity with global regulations for reporting
  • The Customer Quality Clinician provides guidance to complaint handling specialist regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint.
  • The Customer Quality Clinician provides clinical guidance and validates correct coding and regulatory reporting of complaint files by reviewing daily complaint reports. This individual will maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events.
  • The Customer Quality Clinician assesses customer complaints for potential regulatory reporting, based on product specific criteria. He /she verifies assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling.
  • Directly interface with Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events
  • Interact positively with customers, patients, internal/external business partners and colleagues
  • Adhere and comply to work instructions, standard operating procedures, and regulations
  • Expedite investigations by collaborating with internal/external business partners
  • Achieve productivity targets
  • Fully training within three months of hire
  • Achieve accuracy targets for complaint documentations
  • Participate in projects and events
  • Complaint determination
  • Reportability assessments
  • Conduct follow-ups with complainant, reporters
  • Checking your own work
  • Updating SharePoint
  • Tracking complaints in the process for closure
  • Participate in CAPA activities and act as CAPA task owner as required
  • Updating and revising work instructions
  • Prepare responses to customers
  • All other duties as assigned

PROFESSIONAL EXPERIENCE REQUIREMENTS:

  • Ability to work in a cross-functional matrix environment
  • Active listening/ phone skills
  • Collaboration and teaming skills
  • Critical thinking skills
  • Detail orientation
  • Organization skills
  • Prioritization and multi-tasking skills
  • Strong verbal and written communication skills
  • Knowledge of basic medical terminology
  • Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint)
  • Continuous learner
  • Global mindset
  • Accountability for own work
  • Problem solving/Root cause analysis skills


Qualifications

Required:

Associates Degree

A minimum of 6 years’ business experience

Ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making

Knowledge of basic medical terminology

Strong problem solving/Root cause analysis skills

Strong knowledge of Microsoft Excel (v-lookups and pivot tables)

This position is located in West Chester, PA and will require up to 10% travel.

 
Preferred:

A minimum of 2 years’ experience working in a in a GMP or ISO environment is required, Medical Device or pharma experience

Knowledge of and familiarity with global regulations for reporting

Lean / six sigma training and/or certification is highly desirable

Experience filing MDV and MDRs

Experience in post market regulatory, quality or compliance areas


Primary Location
United States-Pennsylvania-West Chester
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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