Regulatory Affairs Specialist
12 months contract to start with (extendable and potential to convert fulltime)
Norwood, MA 02062
Ideal candidate will have 3-5 years DIRECT experience in clinical operations (planning/conducting/managing clinical research studies). Must be familiar with and be able to comprehend clinical study documents (eg protocols, reports, regulatory documents). Must demonstrate strong verbal skills and exhibit exceptional technical writing skills. Must be willing and able to travel less than 5% domestically, depending upon project need
Works with Siemens POC IVDR Core Team and Siemens Clinical Workstream to ensure all POC products have compliant technical files in place for review/audit by Notified Body, allowing for market of POC products in EU under new IVD regulations. All technical files must be completed and audited on or before 2022. Main responsibility includes completion of Clinical Performance Report and Scientific Validity Report for each POC product.
Works with Siemens IVDR Core Team, Quality and R&D departments to ensure that appropriate levels of clinical/preclinical testing are completed and ready for audit prior to deadline (yr. 2022). Helps develop clinical study protocols and/or advise on appropriate study design as needed.