Clinician II Job

Job description

Clinician II-9490151007DescriptionBiosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinician II, Product Safety and Performance in our Irwindale, CA location.
Hi-Tech meets Medical Devices at Biosense Webster! If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient’s lives and want to be responsible for providing the most innovative technology in the field of cardiac electrophysiology, then Biosense Webster is the place for you! Our vision and mission are clear – be #1 in rhythm solutions globally and cure AF (Atrial Fibrillation), the most common heart arrhythmia. Our products are used by prominent physicians around the world and help improve thousands of patient’s lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation – quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Clinician II, Product Safety and Performance is responsible for activities related to product Post Market safety surveillance and risk management including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues. The Clinician II reviews and prepares reports on aggregate data and provides recommendation for further escalation. The Clinician II prepares complaint trend analysis, product risk assessments including Health Hazard. Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.
The Clinician II supports all applicable MDR/MDV regulatory reporting decisions and provides 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. This person verifies assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling. S/he will compose clinical conclusion to be included in the reports to competent authorities around the world and verify that reports are completed and submitted according to regulatory requirements. S/he will provide clinical guidance and validates correct coding and regulatory reporting of complaint files by reviewing complaint reports. S/he will maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events. This individual assess customer complaints for potential regulatory reporting, based on product specific criteria and will review complaint reports to identify any significant issues that need to be escalated or expedited. S/he will develop malfunction code list and regulatory reporting tables in support of product launch activities (preparing surveillance system to capture data). This person is responsible for initiating, escalating, and presenting critical issues to the right forums such as Corrective and Preventative Actions (CAPA) Review Board (CRB), Risk Management Board (RMB), Quality Review Board (QRB), etc. and investigate Corrective and Preventative Actions (CAPA), as appropriate. S/he will provide guidance to clinical team for complaint and vigilance related matters to be taken into consideration in the development of pre and post market clinical studies, including reviewing the Safety Management Plan and study protocol. S/he ensures Serious Adverse Events from Clinical studies are reported according to regulatory requirements. Under minimal supervision, s/he plans, develops, coordinates, and directs projects with varying levels of complexity. As needed, submits MDRs/MDVs to FDA and work with worldwide groups to assure regulatory compliance in countries outside United States. This individual will provide education and training to employees worldwide about products, best practice to report complaints and return complaint products.
The successful candidate will conduct product development and risk management activities which includes: representing Quality Clinical interests in multi-disciplinary teams during product development; performing 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.
S/he will complete complaint and signal review for Regulatory authorities which includes: providing clinical complaint review as requested from regulatory bodies for individualcomplaints, annual reports or for certificate renewal; coordinate, prepare, or review complaint data for regulatory submissions for domestic or international projects.
QualificationsA minimum of a BS in health science field (4 year degree required) such as MD, Nursing, Registered Pharmacist (RPH), Pharmacist or equivalent is preferred. A 4 year degree is required. A minimum of 2
- 4 years of experience in the pharmaceutical, medical device industry or direct device clinical experience is required. Experience interacting with the FDA, ISO, and Other Regulatory Authorities is required. Regulatory Affairs/ Quality Assurance or complaint handling experience in pharmaceuticals or medical devices is preferred. Experience using vascular interventional devices is preferred. In depth knowledge of medical terminology is strongly preferred. Adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate. Excellent verbal and written communications and analytical skills are required. Understanding of statistical fundamentals. Experience with health hazard evaluations is preferred. Leadership skills and a strong customer focus.
The position is located in Irwindale, CA and may require up to 10% travel.
BE VITAL in your career, Be seen for the talent you bring to work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NAPrimary Location:North America-United States-California-IrwindaleOrganization: Biosense Webster Inc. (6010)Job Function: Medical AffairsCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement