Biomedical Engineer, Regulatory Affairs (Los Angeles)

Posted 1 year ago

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.

Location: Corporate Headquarters, El Segundo, California

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
  • Excellent Trouble Shooting 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

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