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Regulatory and Quality Director

Director of Regulatory and Quality Affairs

R&Q is assisting one of our Medical Device Partners in the search for a Director of Regulatory and Quality Affairs. Our partner is a privately held women’s health company dedicated to bringing products into the market that will enhance women’s lives and empower them to take charge of their health. This is a unique opportunity for an individual looking to be an integral part of a smaller company that has a strong entrepreneurial environment.  The ideal candidate will lead and direct all activities related to Regulatory and Quality. The client currently has one product in the market with additional products in development. The person in this role would work out of the Monroeville, PA office (an eastern suburb of Pittsburgh) in order to contribute collaboratively to this small, but dynamic team. 

Be a part of this passionate team that is innovating women’s health by developing products that are brought to market and accessible to all women. The company was founded in 2009 and remains privately held. The company offers to all of their employees a competitive compensation package with an employee bonus program, comprehensive health care package that covers 90% of the health care cost for individuals as well as family, paid time off and free gym membership.

Basic Function: To oversee and manage the regulatory and quality affairs function for the corporation, with respect to all products in meeting QS regulatory requirements, as well as specifications and quality requirements.

Responsibilities Include:

  • Manage, maintain and report product conformance to engineering and customer specifications through inspection of raw materials, work in process and finished good inventories.
  • Manage all regulatory affairs with respect to the FDA requirements of a medical company having to do with registration and compliance.
  • Manage the set-up and establishment of a QSR operating system for the corporation. Set up a 2nd quality system for the 2nd product in development.
  • Manage the set-up and establishment of the corporations standard operating procedures, etc.
  • Assist in vendor audits and establishing contracts with vendors.
  • Review production process for conformance to quality standards.
  • Manage the reporting and tracking of any significant deviations from quality standards and recommend corrective action to appropriate management.
  • Establish and present regular training for employees on quality issues, and develop programs to encourage each employee to perform quality control as part of operations.
  • Participate in new product development to ensure proper quality assurance and control plans can be implemented prior to beginning production.
  • Visit suppliers to review quality concerns and issues to minimize inspection
  • Act as the direct supervisor of the Document Control Specialist

Education and Work Experience

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science, advanced degree preferred
  • 10+ years related work experience.
  • 5+ years of experience in the medical device industry required - Pharma considered
  • Previous management experience a plus

Requirements

  • Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
  • Global Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
  • Post-Market Complaint/MDR experience
  • Safety and risk management 
  • Computer skills required –Microsoft Office applications; statistical data analysis
  • Expert report writing skills 
  • Strong communication skills
  • Leadership skills required
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