Post Market Surveillance Analyst
6 days ago
Volt Workforce Solution is seeking a highly skilled Post Market Surveillance Analyst to join our team in Maplewood, MN. This is an excellent opportunity for individuals with a passion for regulated environments and a desire to work with cutting-edge technology.
About the RoleThis first shift position involves working closely with cross-functional teams to draft plans and reports, upload data to databases, and ensure timely issue closure. The successful candidate will also be responsible for tracking open items, collaborating with product teams, and maintaining metric reports on the PMS system.
Key Responsibilities:- Draft and implement post-market surveillance plans and reports
- Attend cross-functional team meetings to track open items and ensure timely issue closure
- Collaborate with local and long-distance product teams to develop and maintain requirements
- Ensure compliance to PMS schedules and create/maintain metric reports
To be successful in this role, you will need:
- A Bachelor's degree with 1-2 years' experience in a regulated field environment
- Proficiency with Microsoft Office applications, including Word, Excel, Access, PowerPoint, Project, and Outlook
- Experience collaborating with project teams to drive key initiatives or processes in a global, matrixed organization
- Experience working in regulated medical environments, such as medical devices, pharmaceuticals, or biologics
- Experience analyzing data, including product complaints, clinical studies, and competitive products
- Knowledge of FDA and MDD/MDR requirements concerning medical devices
- Experience with Notified Bodies and International Organization for Standardization (ISO) standards
We offer a competitive salary of $23.35/hr, along with a range of benefits, including health, dental, vision, term life, short-term disability, AD&D, 401(k), sick time, and paid leaves. Our commitment to diversity and inclusion means we are proud to be an Equal Opportunity Employer.
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