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....forensics, incident response, investigation, operations, and academic research. We seek individuals with strong interest in understanding and resolving technical challenges in the national security space. Our group focuses on applied research into the functionality...
...DEDICATED REGIONAL CLASS-A CDL DRIVING OPPORTUNITY! 3 Months Minimum Experience REQUIRED Home Time Every 10-14 Days (2 Full Days) 100% No-Touch Freight What You'll Get: Drive across 7 Western States: CA, NV, AZ, OR, WA, ID, UT Modern fleet with all-...
...testing company in the Florida Panhandle. H2's sister company is looking for an energetic and organized individual to fill our Medical Office Manager job in our Milton, FL location. This job is perfect for a qualified CMA that is wanting to take the next step into medical...
...Job Overview: A member of the surgical team, acting under the direction of a Registered Nurse, who works with the surgeon and RN... ...Completion of an OR Technician training program ~2 3 years of experience ~ Must have strong knowledge with skill being able to scrub...
...Board Certified Behavior Analyst (BCBA) As a BCBA, you change lives every day. You leave... ...to find a company that appreciates your work, values you as an individual, and provides... ...)~ Up to 8 hours/week of work-from-home flexibility ~3 weeks of paid time off...