Mgr Regulatory Affairs - req1193

OVERVIEW

Responsible for pre-market and post-market activities as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on released products. Participate in trade association activities to ensure that the interests of Canon are represented. Provide input and assist in determining the appropriate regulatory strategies for product clearance.

RESPONSIBILITIES

• 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 FDA regulatory 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.
• Provide supervision and training/development of RA staff, as directed by the Director, Regulatory Affairs.
• Provide training to CMSU and CMSC employees on regulatory items.
• Regularly audit CMSU's policies and procedures, as directed by the Director, Regulatory Affairs.
• Track pending FDA submissions (510(k)s, PMAs), IDE, and IRB.

QUALIFICATIONS

• Current knowledge of all laws pertaining to FDA clearance
• 4 Year / Bachelor's Degree in Regulatory or Engineering sciences
• 5 years Direct FDA experience, 3 years management experience
• Min: $107,857 annual equivalency to Max: $151,000 annual equivalency
• Position is remote from anywhere in the USA; candidate will work in PST

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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.