Mar 24, 2022

Chief Regulatory Officer

$125,000 - $150,000 yearly
  • Aesthetics Biomedical Inc.
  • Phoenix, AZ, USA
Full time Manufacturing Quality Regulatory R&D

Job Description

Provide total quality and regulatory management and oversight for all aspects of ABM activities.

Duties and Responsibilities:

  • Establish clear outcomes and reliable milestones for all regulatory projects executed for and on behalf of ABM.
  • Responsible for “bullet-proof” regulatory compliance in all aspects of operations, product development and acquisitions.
  • Oversee the regulatory and quality team members as their activities and responsibilities relate to ongoing regulatory projects.
  • Attend weekly Executive team, Staff, Regulatory, and Product Development meetings and other meetings as required.
  • Participates in all aspects of the ABM Executive Team and staff to fully execute tasks to achieve ABM’s mission, goals and objectives.

Ongoing Work Projects:

  • Fully compliant regulatory systems
    • USFDA QSR
    • USFDA CGMPS
    • ISO 13485
    • Canadian Medical Device Regulations – Medical Device Single Audit Program
    • CE Marking from Medical Device Directive
    • IMCAS
  • Day-to-day regulatory and quality operations and oversight
  • Prepare and maintain STED Files
  • Prepare and maintain Risk Management Files
  • Consolidate all designs into ABM Design Master Files
  • Usability and Human Factors (where necessary)
  • Provide template for soliciting key information from potential acquisitions to facilitate quick evaluation of potential devices
  • Prepare and submit regulatory applications as needed for ABM products and devices.
  • Travel to partner facilities to evaluate technology and perform audits
  • Other quality and regulatory services as may be needed to advance ABM’s goals
  • Oversee ABM activities to ensure full compliance with all regulatory requirements in appropriate countries and jurisdictions.
  • Overseeing test of devices to ensure ABM is compliant

Specific Ongoing Projects

  • Oversee company medical device and skincare research and studies necessary to support formal submissions domestic and international regulatory bodies to obtain appropriate licensing. Implement recommendations from pre-submission meeting with to advance regulatory clearance.
  • Oversee TUV SUD audit related to MDSAP
  • Obtain Regulatory registration for Vivace in Mexico and Canada
  • Facilitate regulatory strategy to distribute company medical devices and skincare products world-wide.

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