Description
Key Features -- Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
- Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
- Manage submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
- May review, interpret, and report to the head of Regulatory Affairs on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with the head of Regulatory Affairs to develop strategic and tactical responses to influence a reasonable regulatory environment.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- Manage the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
- Regulatory Submissions for Medical Device Product clearance/Approval s (pre-IDE, 510k), solid and current PMA experience, IVDs submissions a strong plus
- Interface/written communications with FDA
- International Submissions - Design Dossier and Technical File Development
- Lead CE mark projects
- Interactive skills with cross functional project teams (Product development, Marketing, Clinical Affairs, etc.)
Education / Skills -
B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred. Regulatory Affairs Certification preferred.
To find out more about Real please visit www.realstaffing.com