Job Details

Regulatory Affairs Specialist - Post Market

Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations.

Responsibilities:

• 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

Qualifications:

• 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)

About Us:

Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family.