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.
...Support for Growing your Business What we look for in our partners: Experience in installing home improvement products such as roofing, siding, gutters, windows and doors, or bath and showers. Craftsmanship and Pride Effective Communication Willingness to...
...At Five Below our growth is a result of the people who embrace our purpose: We know life is way better when you are free to Let Go & Have Fun in an amazing experience, filled with unlimited possibilities, priced so low, you can always say yes to the newest, coolest stuff...
...within the hospitality industry and beyond. We collaborate with hotels, resorts, and other businesses nationwide to deliver expert-... ...is your talent and a great attitude. Job Summary: The Laundry Attendant is responsible for ensuring that all linens, towels, and...
...Our growth depends on strategic, missionaligned fundraising and thats where you come in. Role Overview The Grant Lead / Development Manager is the engine behind Outcome Schools fundraising success. You will oversee the full lifecycle of grant development ...
HCA Healthcare is seeking a dedicated and skilled OR PRN RN for a call-only position to join our dynamic team. In this role, you will... ...procedures. This position requires availability to cover shifts on an on-call basis with a focus on weekends, holidays, and non-standard hours.