Johnson & Johnson Careers

Customer Quality Regulatory Specialist II

Raynham, Massachusetts
Quality (Generalist)

Job Description

Requisition ID: 7749180402

DePuy Synthes Companies of Johnson & Johnson is seeking a Customer Quality Regulatory Specialist II to be located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.
Customer Quality member is responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include the submission of Health Authority Reporting and responses. The Customer Quality Regulatory Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. You will oversee workflow to ensure timely health authority reporting. We are counting on you to be knowledgeable regarding regulations and standards affecting Medical Devices (e.g. ISO9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc.), CMDR, and Medical Devices Directive (93/42/eec, 98/79/EC)).
  • Prepares and submits Medical Device and/or Health Authority Reports within the required timelines. Responsible and accountable for the accuracy and timeliness of submitted regulatory reports and Health Authority Requests. Acts as a subject matter expert for completion of health authority reports for initial/follow-up/or final Health Authority Report
  • Prioritizes work per needs of department to support regulatory reporting and complaint investigation timeliness.
  • Works with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems
  • Prepares responses to customer inquiries regarding complaint investigations and prepares trend reports for complaints.
  • Serves as a liaison between the quality assurance department and other departments for complaint investigations.
  • Communicates effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Sales, Supply Chain and Marketing to provide quality input.
  • Tracks metrics on process timeliness and effectiveness; Participates in process improvement activities.
  • Serve as a subject matter expert during audits, inspections and assessments by regulatory agencies and corporate bodies.
  • Lead or own CAPA/NC/DR’s and ownership of document change management
  • All other duties as assigned

  • Minimum of Bachelor’s Degree in a technical discipline is required. An advanced degree is a plus.
  • Minimum of 2 years of direct or related experience in a regulatory environment is required.
  • RAC or ASQ certifications a plus
  • Excellent problem solving, critical thinking, and decision making skills is required. Ability to conduct root cause analysis is required.
  • Ability to prioritize and multi task.
  • Working knowledge of the QSR Part 820 and ISO 13485 & 14971 quality requirements is preferred.
  • Ability to collaborate with technical and non-technical personnel at all organizational levels. Ability to work in a cross-functional and matrix environment; strong verbal and written communication skills.
  • Demonstrates ability to respond to the urgent needs of the team, with proven track record of meeting deadline.
  • Knowledge of basic medical terminology.
  • Proficient in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint).
  • This position is located in Raynham, MA and may require up to 5% travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
Primary Location
United States-Massachusetts-Raynham
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Generalist)
Requisition ID