Sarah Batchelor Email & Phone Number

Sarah Batchelor possesses expertise in microsoft office, powerpoint, autocad, medical devices, fda and 11 more skills. She is proficient in English. Colleagues describe her as "Sarah’s application of quality principles was balanced and detailed. Her conscientious, capable and focused efforts were tailor made for our small medical device startup company. I would welcome an opportunity to work with her again." and "Sarah is very responsible, clever and perfectly organized colleague. Being a quick learner, she would be a valuable addition to any team, and I would be happy to work with her in the future, should circumstances allow. Being a lead assay development scientist on IVD medical device 510(k) project, I had a chance to work with Sarah for over a year, starting with her appointment as a QA engineer in charge of supervising content of the device Design History File (DHF). In this role, her responsibilities included ensuring adherence to regulatory standards in documentation on assay chemistry, validations and clinical trial with me, and also documentation on instrument hardware and software with other functional project leaders. Observing from my side, I cannot grade her performance as anything less than outstanding. She was extremely proficient not just on regulatory side, but also in critical reading of my documentation, being able to uncover several potential deficiencies and was instrumental in discussing ways to fill those gaps in documentation. She was always open to take on new assignments and did whatever it took to have her part done in a timely manner. Over the course of the project, her responsibilities further expanded as she took lead being in charge of support, maintenance and QA review of the device Clinical Trial database as well as ongoing communication and monitoring of the Clinical Trial sites and coordinating interactions with CRO. Her outstanding performance was duly noted by the company leadership team, and she was quickly promoted to a position of Quality and Regulatory Affairs Manager. Acting in this capacity, she oversaw preparation of 510(k) submission package, and participated all the way into submission and following-up on questions with FDA."

Listed skills include Microsoft Office, Powerpoint, Autocad, Medical Devices, and 12 others.