Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
Business Analyst (Analytics & Actuarial Services)We are seeking a Business Analyst (Analytics & Actuarial Services) to join our team at Independent Living Systems (ILS). ILS, along with its affiliated health plans known as Florida Community Care and Florida Complete Care...
...Bus Mechanic Term of Employment - 12 months Salary - NC State Salary Schedule - Grade based on experience/qualifications Reports to: Transportation Supervisor General Definition of Work Performs intermediate skilled trades work performing vehicle maintenance...
Rize Alliance Properties is seeking a Communications & Advocacy Associate to elevate and expand the role of local humanitarian organizations. This role blends strategic communications with engaging external stakeholders, advancing Auroras mission. Key responsibilities...
...Join us in making a difference! The Red Cross is looking for passionate individuals to join our team of volunteers. Explore multiple volunteer roles and find the perfect fit for your passion and schedule. Together, we can create lasting change in your community! Disaster...
...remodeling and/or fixing things in homes, buildings, or hotels. # Experience in basic electrical and plumbing, light carpentry, appliance repair, painting, mechanical knowledge and HVAC heating and air conditioning (if you're EPA Certified). # Self-starter who can work...