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Manager Regulatory Affairs

Company Name: Canon Medical Systems
Location: Tustin, CA
Job Type: Full Time
Contact Name: Nancy Anderson
Phone: 714-669-7617
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.


Job Description


Job Summary


Responsible for pre-market activities as assigned by the Senior Manager Regulatory Affairs to include new product planning. Participate in
trade association activities to ensure that the interests of Canon Medical Systems are represented. Provide input and assist in determining the appropriate regulatory strategies for product clearance.

When required will work with and or supervise post market staff with remedial actions on released products.

Essential Responsibilities

• Assist in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Senior Manager or the Director, Regulatory Affairs.

• Track pending FDA submissions (510K’s, PMAs), IDE, and IRB

• Audit CMSU policies and procedures as assigned by management

• Support legal actions as required by the legal department or directed by the Regulatory Affairs Management

• Provide training to CMSU and CMSC employees on regulatory related items
• Review collateral materials for conformity to market clearances
• Review training materials for service and applications
• Participate in NPI meetings as required by Regulatory Affairs Management

Job Requirements

Position Requisites

• Minimum 5 years direct FDA experience.

• Current knowledge of all laws pertaining to FDA clearance.

• Prefer B.A., B.S. or advanced degree in Regulatory or Engineering sciences.