At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

　　As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

　　What You Can Expect

　　The Product Surveillance Specialist is responsible for:

　　Supports a defined process and adheres to all corporate and site specific procedures, executes the process with a focus on a defined process steps, and makes decisions regarding defined process steps:

　　Perform complaint handling responsibilities with the objective of supporting compliance, quality, and timeliness. Ensure on-time and complaint reporting of Medical Device complaints to the FDA.

　　Determine reportability based on adverse event or device malfunction and submit Medical Device Report (MDRs) and Medical Device Vigilance (MEDDEV) to Regulatory Authorities in accordance with company standards and regulatory requirements. Reference site procedures or site Reportability Guidance Document (RGD).

　　Follow-up with reporter for additional information about event notification received to complaints team or by Zimmer Biomet Product experience report (ZPER) filled. Review additional information received from reporter and ensure complaints are timely entered in ETQ Reliance Complaint Handling Application.

　　Provides guidance and feedback to other team members pursuant to the defined procedures and follow up with division personnel, site team, and international team members to ensure effectiveness and responsiveness related to process.

　　Follow-up with foreign government and/or distributor to get additional information about the reported event.

　　Collaborate with department and international team members to timely support responses to Regulatory Inquiries requested by foreign governments.

　　Assist peers with complaint processing and reporting as a back-up while team members are on PTO, during increase of complaints or when has bandwidth for additional support.

　　Responsible for communication of data related to the process to site and division leadership:

　　Proactively monitor and address action items required outside of company's control to avoid aging complaints. A distribution and registration search will be completed for each part number of the product on the complaint to ensure Decision Trees and Action Items are created in ETQ.

　　How You'll Create Impact

　　Identifies and investigates solutions to procedure and process related issues. Revises the procedure or process as needed to increase efficiency and compliance:

　　Attend management training on revising procedures or processes as needed to increase efficiency and compliance. Based on the training, revise workflow procedure or new application to improve work efficiency.

　　Documents and maintains records in accordance with corporate and site specific procedures:

　　Perform complaint processing activities such as entering complaints in ETQ on-time, perform due diligence, update complaint is per additional information is received, submitted reports on time to regulatory authorities, create appropriate Decision Trees and Action Items for further device investigation in ETQ.

　　Document objective evidence to support and make reportability decisions, such as but not limited to due diligence.

　　Follow Good Documentation Practices.

　　Creates, maintains and monitors appropriate metrics to measure the key performance indicators of the unit:

　　Review daily reports to ensure there are no MDR or MEDDEV reports pending that could cause a late report to regulatory authorities.

　　Conduct final assessment to document all the available information reported on complaint file entered in ETQ is being reported to FDA.

　　Assists Management in special projects as required:

　　Sample projects includes review of decision trees for major transit packaging complaints entered in ETQ. Review the device reported on complaints and confirm if it is an alliance partner device and verify accuracy. If accurate, complete the decision tree.

　　How You'll Create Impact

　　Your Background

　　Requires a bachelor’s degree in Biology, Heath Sciences, Engineering Management, Nursing or related field.

　　Must have 3 years of experience in medical device industry position or related.

　　Must have:

　　3 years of experience with EtQ, JD Edwards, Internet, Microsoft Office Applications.

　　3 years of experience with writing reports and developing metrics.

　　3 years of experience working in the medical device industry.

　　2 years of experience with Risk Management techniques and principles.

　　Travel Expectations

　　Up to 5% domestic travel. Remote work / telecommuting permitted throughout US.

　　EOE/M/F/Vet/Disability