Biomedical Engineer, Regulatory Affairs (Los Angeles)

Radlink is seeking a talented, experienced Biomedical Engineer to manage Regulatory Affairs and Field Engineering. Applicants should have strong knowledge of Quality Systems and leading Medical Device Regulations, including FDA 510k and ISO 13485. Principal Duties and Responsibilities Oversee and manage yearly regulatory audits Provide support to hospitals working with Surgeons in the operating room Provide field support for products and services for the company’s End Users Perform product trials, in coordination with hospitals Perform installation of equipment and training for End Users and Distributors Desired Skillsets Hands-on support and service experience in health-care or medical device industry in support of end users Excellent telephone skills Knowledgeable in computer and network administration Technical competence in using and trouble-shooting medical devices Familiarity with medical imaging, DICOM and PACS Excellent communications and writing skills Willing to Travel Education and Experience Experience working in the medical device industry, imaging equipment or technology Four-year college degree in engineering, mathematics, science or similar technically oriented program Proficient in use/set-up of computer systems, PACS or other hospital networks #J-18808-Ljbffr