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Mgr Regulatory Affairs Sr

2 months ago

Denver, United States Canon USA & Affiliates Full time

Mgr Regulatory Affairs Sr - req1224

OVERVIEW

Manages the day to day activities of the Regulatory Affairs (RA) pre-market group. 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 Medical Systems 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 leadership to include supervision and mentoring of pre-market RA staff

  • Provide guidance to CMSC Business Unit Managers and Engineering Managers in FDA Approval 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 training to CMSU and CMSC employees on regulatory items.

  • Regularly audit CMSU's policies and procedures.

  • Track pending FDA submissions (510's, PMA's), IDE, and IRB.

  • Serve in lieu of the Director Regulatory Affairs as required.

  • Position will work in PST (8:30am to 5:00pm PST)

  • Range in $178,000 base salary plus performance incentive with upside potential.

QUALIFICATIONS

  • Current knowledge of all laws pertaining to FDA clearance.

  • 10 years Direct FDA experience and management experience.

  • 4 Year / Bachelor's Degree in Regulatory, Engineering or physical sciences.

  • Position will work in PST (8:30am to 5:00pm 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.