Radlink, Inc.
Biomedical Engineer, Regulatory Affairs (Los Angeles)
Radlink, Inc., Los Angeles, California, United States, 90079
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
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 troubleshooting 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
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Industries: Medical Equipment Manufacturing
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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 troubleshooting 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
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Industries: Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Radlink, Inc. by 2x
Get notified about new Biomedical Engineer jobs in Los Angeles, CA.
#J-18808-Ljbffr