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Zimmer, Inc. Clinical Post Market Surveillance Associate Specialist (680597) - AMER21678-352010 in Warsaw, Indiana

Job SummaryZimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.In this role, you will be responsible for clinical post market surveillance (PMS) assignments; including providing support in the development of initial PMS plans, revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS review according to the PMS schedule.Principal Duties and ResponsibilitiesProvides support for Post Market Surveillance Activities; Initial PMS Plans (PMSP) and Review (PMSR) records; responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable).Ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified BodiesScheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at-risk findings to senior managementTrack execution of PMS plan according to requirements; report to management on track, delayed and at risk PMS commitments; project management of PMS action items to ensure deadlines metSupports routine audits of PMCF commitments against PMSP to ensure quality and transparency of commitments is maintained.Expected Areas of CompetenceStrong communication skills, both written and verbal; developed intrapersonal skills and work in a fast paced environment prone to change. Strong attention to detail and ability to manage multiple projects and meet deadlines.Basic knowledge of Global Medical Device regulations relative to Post Market Surveillance (Medical Device Directive and Revisions, ISO 14155, FDA Section 515 and 522, FDA MDR requirements, etc.) is preferred.Proficiency with Microsoft Office suite, and advanced spreadsheet or Microsoft Excel experience preferred.Education/Experience RequirementsBachelors Degree requiredMedical Device Functional Experience (Clinical, Engineering, Regulatory, Quality, etc.) strongly preferredTravel RequirementsLess than 5%Additional InformationEOE M/W/Vet/DisabilityAt Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.Compensation Range: $51,400-$64,000Equal Opportunity Employerminorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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