Biomedical Engineer, Regulatory Affairs; Los Angeles

Biomedical Engineer, Regulatory Affairs (Los Angeles)

3 days ago Be among the first 25 applicants

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

• 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

• 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 troubleshooting medical devices
• Familiarity with medical imaging, DICOM and PACS
• Excellent communications and writing skills
• Willing to travel

• 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

• Mid‑Senior level

• Full‑time

• Research, Analyst, and Information Technology
• Industries:
  Medical Equipment Manufacturing

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