Offer summary

Qualifications:

Minimum of 2 years of Regulatory Affairs experience in the medical device industry., Associate's degree required; Bachelor's degree in STEM preferred., Strong interpersonal, communication, and organizational skills., Proficiency in MS Word, Excel, Oracle, and Salesforce..

Key responsibilities:

Coordinate complaint handling and reportable events processing.

Assist with FDA recall filings and monitor regulatory compliance.

Manage electronic submissions and state registrations.

Represent Regulatory Affairs in cross-functional teams.

Mission Canon Medical Systems USA delivers innovative imaging solutions and services through our Made for Life philosophy to improve the quality of life for all people. Our Heritage Canon Medical Systems is born from two global leaders—Canon and Toshiba Medical. In business for more than 100 years, Toshiba Medical was built to improve the quality of life for all people. It delivered on this mission with medical innovations that are Made for Life—made to improve the lives of patients, clinicians and administrators. Its legacy was built with pioneering medical technology, such as the world's first X-ray machines in 1932 and Japan's first Magnetic Resonance Imaging systems (MRI) in 1983. Toshiba Medical’s vision was strengthened in 2016 with its acquisition by Canon. Canon entered the healthcare business in 1940 with the development of Japan’s first indirect X-ray camera which was used for the early detection of pulmonary tuberculosis. The partnership of these two companies (now Canon Medical Systems Corporation), brings together two cutting-edge technology businesses, founded with similar values of creativity, flexibility and patient-friendly healthcare solutions. Today, their combined history of research and innovation drive forward Canon Medical Systems’ vision for building a world-class healthcare enterprise.

Job description

Remote position, west coast hours mandatory
Coordinate the complaint handling process to include processing of reportable events
Provide information as requested for the filing of FDA recalls
Coordinate FMI process, including monitoring and reporting status and completion
Process electronic submissions (e.g. 3500A, 2579, Product Reports, Annual Reports)
Coordinate state registrations, including monitoring regulations and preparing and submitting documentation to each state as required
As requested, write/review CMSU policies, procedures and guidance documents incorporating regulatory requirements/actions
Assist in maintaining proper preparedness for State or Federal (FDA) authorities
Represent interests of RA in cross functional teams as needed

Excellent interpersonal, communication, and organizational skills
Ability to develop and maintain effective working relationships internally and externally
Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc.
2 Years Regulatory Affairs experience in medical device industry required
Minimum Education Level: 2 Year / Associate's Degree
4 Year/ Bachelor's Degree (STEM) preferred
Pay Information: Min. salary of $72,000 to max $116,100 (annual equivalency)

Required profile