Job Summary and Primary Responsibilities
The Post Market Surveillance (PMS) Specialist will collect, analyze, trend and report on post market data to proactively identify potential adverse safety risks or performance trends. Develops and implements solutions to streamline flow of information and returned material related to Post-Market Surveillance activities. Working cross-functionally, identifies and supports the resolution of issues through the coordination of investigations, identification of adverse trends, and management of complaints and product performance processes.
- Ensure post market surveillance compliance to applicable regulatory requirements.
- Update Post Market Surveillance (PMS) plans
- Generate PMS Reports, Periodic Safety Update Reports (PSURs), and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents
- Extract and generate PMS and operational performance data necessary for generating applicable reports
- Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity
- Lead efforts to ensure actions from PMSR and PSUR are implemented
- Provide data analyses in support of internal and external customers as needed, including data related to customer correspondence, surgeon meetings, site visits and regulatory agency correspondence
- Support cross-functional teams in responding to requests for additional information from competent authorities, registries and notified body
- Collaborate with cross-functional teams to support, implement, and/or maintain post market surveillance activities and feedback into internal processes (Risk Management, Quality, Development, Marketing, etc.), ensuring a closed loop quality management system
Required Skills / Capabilities
- Collaborate with cross-functional teams to support, implement, and/or maintain post market surveillance activities and feedback into internal processes (Risk Management, Quality, Development, Marketing, etc.), ensuring a closed loop quality management system
- Familiar with Risk Management files
- Must have strong Microsoft Excel capabilities, including experience in standard formula building, IF statements, standard calculations, Vlookup, charting/graphing, pivot tables
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and/or concrete variables
- Task Oriented with excellent communication skills; responsible for gathering data and writing quality and regulatory documents
- Ability to work in a team-oriented environment, navigate multiple projects with changing priorities and meet project timelines
Education and Experience
- Bachelor's degree in engineering, life science, or a combination of education and experience providing equivalent knowledge
- A minimum of 5 years of complaint handling experience and/or post-market surveillance in the medical device or a regulated industry
- Working knowledge and experience with US FDA 21 CFR 803 Medical Device Reporting, US FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD, vigilance reporting requirements, PMDA
Travel and/or Physical Requirements
None
Salary Range: $96,000 - $160,000
California Salary Ranges and Pay Framework
For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The "EEO is the Law" poster options are available here . NuVasive's EEO policy is available here .
About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com .
