Clinician, Product Safety & Performance (1 of 4)
DePuy Synthes Companies of Johnson & Johnson is seeking a Clinician, Product Safety & Performance.
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.
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. You will prepare complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs.
- 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.
- Provide clinical guidance and validates correct coding and regulatory reporting of complaint files by reviewing daily complaint reports.
- Maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events.
- 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.
- Evaluate investigational findings for appropriateness and any significant issues.
- Review technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports.
- Review weekly complaint report to identify any significant issues that need to be escalated or expedited.
- Develop malfunction code list and regulatory reporting tables is support of product launch activities (preparing surveillance system to capture data).
- 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.
- Complete health hazard evaluation assessments.
- Review monthly safety surveillance data with manufacturing sites.
- Represent Quality Clinical interests in multi-disciplinary teams during product development.
- 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.
- 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.
- Ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes from both a compliance and business perspective.
- 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.
- Provide education and training to employees worldwide about products, best practice to report complaints and return complaint products.
- Participate in site or global projects and improvement efforts, as needed.
- Participate in internal or external audits.
- Additional duties as assigned.
- 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.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- A minimum of a Bachelor degree or higher is required
- 6+ years professional experience, including some practical nursing with a minimum of 4 years in a GMP and/or ISO regulated industry is required.
- Experience in the pharmaceutical, medical device industry or direct device clinical experience is preferred.
- In depth knowledge of medical terminology is required.
- Experience in orthopaedics is preferred.
- Regulatory Affairs/ Quality Assurance or complaint handling experience in pharmaceuticals or medical devices preferred.
- Experience with health hazard evaluations is preferred. Experience interacting with the FDA preferred.
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.
United States-Florida-Palm Beach Gardens
North America-United States
Depuy Orthopaedics. Inc. (6029)
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