Position Summary
The Regulatory Affairs Specialist is responsible for ensuring DemeTECH Corporation complies with the regulatory requirements of FDA, ISO, EU MDR, Health Canada, CFDA, and other applicable authorities. This role leads pre-market and post-market regulatory activities including 510(k) and Technical Documentation submissions, PMS reporting, UDI compliance, and sterilization documentation. The position is also responsible for cross-functional regulatory guidance, audit preparation, and international market registration.
Key Responsibilities
Minimum Education Requirements
Required Competencies & Qualifications
Desirable Attributes
...ECEAP/Early Head Start provides care and support for more than 1,600 children and their... ...dental); mental health; nutrition; and disability education, resources, and referrals ensuring... ...by Spokane Colleges). ~ Valid Food Workers Card (as available through Washington State...
...opening a NEW Youth ACT program in Sullivan County, NY. The Youth ACT Team Leadplays a key role in guiding and supporting staff, leading team planning meetings, and providing clinical direction. They offer individual supervision, work alongside staff, and deliver direct...
...Job Description An active family is seeking an experienced, nurturing, and highly organized Private Nanny to support their large household. The ideal candidate is confident, caring for multiple children, enjoys creating structure, and thrives in a dynamic environment...
...Job Description General Summary: As Vertex continues to expand its pipeline, in our commitment to serving patients, we are offering an exciting opportunity to join our Analytical Development team. We are actively seeking an analytical project leader to support small...
Senior Level JIRA Admin/Engineer Position , focused on the infrastructure side, performing installs, patches, and server management. Strong experience with AWS in a containerized environment.Configure, maintain, and troubleshoot JIRA Data Center and server instances,...