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Mgr Regulatory Affairs

Remote: 
Full Remote
Salary: 
130 - 130K yearly
Experience: 
Senior (5-10 years)
Work from: 
California (USA), United States

Offer summary

Qualifications:

Bachelor’s Degree in regulatory, engineering, or physical sciences, 5 years direct FDA experience.

Key responsabilities:

  • Plan meetings between FDA and CMSU
  • Provide guidance on pre-market submission preparation

Canon Medical Systems USA, Inc. logo
Canon Medical Systems USA, Inc. Large https://us.medical.canon/
1001 - 5000 Employees
About Canon Medical Systems USA, Inc.
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.
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Job description

  • Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs.
  • Provide guidance to CMSC Business Unit Managers and Engineering Managers in pre-market submission preparation.
  • Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's as assigned by the Director, Regulatory Affairs.
  • Support legal actions as required by the legal department or directed by the Director, Regulatory Affairs.
  • Support training/development of RA staff.
  • Provide training to CMSU and CMSC employees on regulatory items.
  • Audit CMSU's policies and procedures, as required.
  • Submit and track pending FDA submissions (510K's, PMAs), IDE, and IRB, as applicable.

,

  • Current knowledge of all laws pertaining to FDA clearance.
  • 4 Year/Bachelor’s Degree in regulatory, engineering, or physical sciences.
  • 5 years Direct FDA experience.
  • Will work PST hours, prefer candidate to reside on the West Coast. Potential in-person meetings 1x per month or so.
  • Range in $130,000 base salary plus performance incentive with upside potential. DOE.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsFDA RegulationsJetBrains IDE

Other Skills

  • Training And Development
Are you interested?

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