Clinician, Product Safety and Performance-8953141104
Description
DePuy Synthes Companies is currently recruiting for a Clinician, Product Safety and Performance located in Palm Beach Gardens, FL.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.
The Clinician, Product Safety and Performance is responsible for activities related to product safety surveillance and risk management including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues. He/she reviews and prepares reports on aggregate data and provides recommendation for further escalation. This individual will prepare complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs.
The incumbent will provide 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. They provide clinical guidance and validate correct coding and regulatory reporting of complaint files by reviewing daily complaint reports, and maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events. They assess customer complaints for potential regulatory reporting, based on product specific criteria, verify assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling, compose clinical conclusion to be included in the reports to competent authorities around the world, and evaluate investigational findings for appropriateness and any significant issues.
The Clinician, Product Safety and Performance will review technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports. They review weekly complaint report to identify any significant issues that need to be escalated or expedited, and develop malfunction code list and regulatory reporting tables is support of product launch activities (preparing surveillance system to capture data). They monitor customer complaint data for product quality trends, review monthly surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns, and complete health hazard evaluation assessments. They review monthly safety surveillance data with manufacturing sites and represent Quality Clinical interests in multi-disciplinary teams during product development. They will perform clinical 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.
The incumbent is responsible for evaluation and review of non-Clinical contributions to risk management documents such as FMEA's, Risk Management Plans and Risk Management Reports for conformance to procedure, completeness, content and accuracy. They ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes from both a compliance and business perspective. They act as Clinical representative for clinical changes and non-regulatory change assessments to Instructions for Use, provide clinical complaint review as requested from regulatory bodies for individual complaints, annual reports or for certificate renewal, coordinate, prepare, or review complaint data for regulatory submissions for domestic or international projects, and provide education and training to employees worldwide about products, best practice to report complaints and return complaint products. They participate in site or global projects and improvement efforts, as needed, participate in internal or external audits, and perform additional duties as assigned. They must know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. They will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
A minimum of an Associate's Degree in an applicable scientific discipline is required. A Bachelor's Degree in an applicable scientific discipline is preferred. A health science field license (i.e. Registered Nurse (RN), RPh, Pharm.D) is required. A minimum of 4 years of experience in a GMP and/or ISO regulated industry is required. Candidates who do not possess 4 years of experience in a GMP and/or ISO regulated industry will be considered, if you have a minimum of 6 years’ experience in a nursing/clinical environment. Experience in the pharmaceutical, medical device industry and/or direct device clinical experience is preferred. In-depth knowledge of medical terminology is required. Previous experience in orthopaedics is preferred. Previous MDR experience is preferred. Regulatory Affairs, Quality and/or complaint handling experience in pharmaceuticals and/or medical devices is preferred. Experience with health hazard evaluations is preferred. Experience interacting with the FDA is preferred. Excellent communications and analytical skills are required. Working knowledge of Microsoft Office, Excel, Power Point, and Access is required.
This role will be based in Palm Beach Gardens, FL and requires up to 25% travel with the possibility of international travel.
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J2W:NA LI
Primary Location:North America-United States-Florida-Palm Beach Gardens
Organization: Depuy Orthopaedics. Inc. (6029)
Travel:Yes, 25 % of the Time
Job Function: Quality Assurance
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