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Customer Quality Clinician Safety and Performance ClinicianCompany Johnson & Johnson Family of Companies
Location West Chester, PA
Update 8 Day ago
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies 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, more agile and better equipped to meet the needs of 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 Clinician is responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and Health Authority reporting. These activities include making regulatory reporting decisions to FDA and other competent authorities. You'll work collaboratively with Medical Safety, Customer Quality Engineering, Manufacturing, Product Development and other functional experts to assist in regulatory assessments or to support the Reportable Malfunction List. We need someone 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.
We need you to handle activities related to product safety surveillance and risk management including review of data from clinical studies.
You'll review and prepare reports on aggregate data and provides recommendation for further escalation including the preparation of complaint trend analysis for Regulatory Authorities as requested
The Customer Quality Clinician is responsible for maintaining the reportable malfunction list in collaboration with Medical Safety and Customer Quality Engineering.
We need you to review applicable MEDDRA terms, Harms Tables, and DCRM’s to support regulatory decisions as needed. Position duties & responsibilities:
Provides guidance to complaint handling specialists 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.
Assesses customer complaints for potential regulatory reporting, based on product specific criteria. We need you to verify assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling.
Reviews correct coding of complaint files by reviewing daily complaint reports. You will maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events.
Documents clinical conclusions regarding the reportability assessment in the complaint record.
Reviews technical investigations for returned product analysis in their assessment for reportability based on applicable regulation.
Participates in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of product launch or complaint management database activities (preparing surveillance system to capture data).
Represents clinical interests in multi-disciplinary teams during product development
Perform reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA's, Risk Management Plan, Risk Management Report and Clinical Evaluation Report in support of new product development and regulatory requirements.
Coordinates, prepares, and/or reviews complaint data for regulatory authorities as requested.
Provides education and training to employees regarding regulatory decisions and assessments.
Participates in regulatory audits as requested including front room if needed.
The following degrees will be considered for this role:
At minimum a Biomedical engineering degree or Bachelor’s Degree in Nursing, Life Sciences or Health Sciences is required.
6+ years of professional experience is required.
4+ years in a GMP and/or ISO regulated industry strongly preferred.
A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is also strongly preferred.
RAC or ASQ certifications are preferred.
Experience in post market regulatory, quality or compliance areas is preferred. The ability to work independently and prioritize with little supervision is required.
Strong written and oral communication and interpersonal (listening) skills is required.
The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required.
Analytical and critical thinking skills are required.
Excellent organizational and time management skills are required.
Strict attention to detail is required.
Familiarity with basic quality tools and techniques is preferred
This position will be based in West Chester, PA or Raynham, MA or Elmira, NY, or Palm Beach Gardens, FL, or Warsaw, IN and will require up to 10% travel, including potential international. 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 are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-West Chester
North America-United States-Indiana-Warsaw, North America-United States-Florida-Palm Beach Gardens, North America-United States-New York-Elmira, North America-United States-Massachusetts-Raynham
Depuy Orthopaedics. Inc. (6029)