Johnson & Johnson Careers
Customer Quality Regulatory Specialist III
Palm Beach Gardens, Florida
Requisition ID: 2391180920
DePuy Synthes Companies of Johnson & Johnson is seeking a Customer Quality Regulatory Specialist III located in Palm Beach Gardens, FL.
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.
You, the Customer Quality Regulatory Specialist III will be responsible for supporting all Post Market Regulatory Affairs activities associated with complaint handling and Medical Device Report submissions. These activities include intake, investigation, documentation, follow-up, reportability determinations, regulatory reporting and metrics. You will be responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. You will work collaboratively with Quality, Engineering, Manufacturing, Business Quality, Local Operating Companies, Product Development and other functional experts.
Responsibilities include but are not limited to:
- 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.
- Assess worldwide 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.
- Prepare and/or review completed portions of regulatory submissions and complete international vigilance and reports of adverse events as required.
- Responsible and accountable for timeliness and accuracy of response to Health Authority Requests
- Serves as a liaison between the quality assurance department and other departments to ensure timely and accurate completion of complaint investigations.
- Will be responsible for processing and closing complaints in a timely manner.
- Will be responsible for identifying and implementing process improvements.
- This individual will maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals.
- This individual will serve as a Subject Matter Expert (SME) for regulatory determinations and/or regulatory reporting for all cross-functional teams.
- Provide support and/or perform Non-Conformance Investigations, Field Actions, Documentation Management and Metrics.
- 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.
- Additional duties as assigned.
- A minimum of an LPN (Licensed Professional Nurse) or LVN (Licensed Vocational Nurse certification is required. A bachelor’s degree and/or Registered Nurse is preferred.
- Generally require 6 years professional experience, with a minimum of 4 years in a GMP and/or ISO regulated industry is required.
- Experience in post market regulatory, quality or compliance areas 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.
- Familiarity with basic quality tools and techniques is preferred.
- Analytical and critical thinking skills are required.
- Excellent organizational and time management skills are required.
- RAC or ASQ certifications are preferred. Strict attention to detail is required.
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-Florida-Palm Beach Gardens
Depuy Orthopaedics. Inc. (6029)