This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.
Provides regulatory affairs project management for various areas, to include regulatory submissions for new products, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets. Co-ordinates preparation of well organized, complete and scientifically sound regulatory submissions. Interfaces directly with various regulatory agencies, as required, to facilitate the timely review and approval of regulatory applications. Responsible for filing necessary applications and handling government interactions pertaining to the regulation process for products requiring regulatory approval. Provides guidance on regulatory requirements and strategies to product development project teams. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises judgement within generally defined practices and departmental standard operating procedures. Maintain expert working knowledge of relevant laws, regulations and enforcement decisions. Knowledge of EU MDR requirements and other applicable EU regulations as they relate to Class III implantable medical devices. Authors and submits clinical trial applications under EUMDR and applications for CE mark. Proven successful track record of authoring/submission/approval of Class III implantable devices in EU. Authors and submits IDE and PMA submissions, as well as supplements (5-Day Notice, 30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports etc.). Knowledge of FDA guidance documents and CFR regulations....implementing strategic joint business plans with vendors. The Amazon Vendor Services Team works with Vendors who sell products such as: Home & Lifestyle (Toys, Furniture, Kitchen, Music/Video, Major Appliances, Home Improvement, Lawn and Garden, etc.) Our goals include...
...analysis For example Big Four Public Accounting Firms Client PricewaterhouseCoopers (PwC) Ernst & Young (EY) KPMG The Accountant 3 will establish and maintain accounting policies, fiscal controls and prepare financial reports and safeguard...
...Shifts and Pay Rates Available: Senior Forklift /Cherry Picker - $22.15 per hour + $.75 shift differential for Night / Weekend Shifts Day (P) Shift: Monday - Thursday, 7:00am - 5:30pm Weekend (R) Shift: Friday - Sunday, 7:00am - 7:30pm Become an essential...
Come drive with usl Whether you're looking for a new career or a second job to earn supplemental income, we're looking for motivated, hardworking individuals who want to learn and grow with the company I Your main responsibility as a delivery driver is to deliver orders...
...Are you an entrepreneur who is fueled by the desire to build companies that support other businesses? Do you have experience in both product leadership and marketing? About Us: Our company Zelkova Ventures has been investing in early-stage SaaS businesses since...