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Director, Regulatory Affairs and Quality Assurance

Organization

More Diagnostics Inc.

Job Location

2020 11th street
Los Osos, CA 93402
United States

Job Description

Essential Functions:

Regulatory Affairs

  • Maintain control of documents needed for production and regulatory compliance.
  • Overall responsibility for assurance of product quality and regulatory affairs which includes compliance with applicable laws and regulations.
  • Coordinate activities of Third Party (Notified Body, FDA) associated audits and corrective action activities.
  • Maintain a library of documents, pictures and examples of items necessary to demonstrate compliance to regulatory requirements to foreign governments.
  • Maintain and update each year the licenses, registrations and certificates to ensure MDI is operating in a legally compliant manner.

 

Quality system oversite

  • Responsible for fulfilling MDI’s quality policy and objectives, including management of an MDSAP, ISO 13485:2016, IVDD compliant quality management system, monitoring root cause analysis and implementation of Corrective and Preventative Action, complaint handling, document control, internal and external audits and the development of quality plans.
  • Reporting on the performance of the Quality Management System (QMS) to top management, including needs for improvement.
  • Work with Operations and Production to maintain all documents, reports and records
  • Develop and conduct effective training programs on related QA topics.
  • Ensure that the company’s QMS processes and products are ingrained in our culture while also compliant with applicable quality standards and requirements

Requirements

Success Factors

  • Proven ability to work as part of a team
  • Solid written and verbal communication abilities
  • Ability to analyze failure, and take corrective and preventive action to respond to internal/external customer complaints
  • Inclination for continuously improving Quality Assurance processes and procedures.

Key Competencies

  • Optimizes Work Processes
    • Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
  • Ensures Accountability
    • Holding self and others accountable to meet commitments.
  • Collaborates
    • Building partnerships and working collaboratively with others to meet shared objectives

Qualifications

  • Bachelor’s Degree in science related field
  • Minimum five years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices
  • Working knowledge of FDA Quality System Requirements, ISO 13485:2016, Medical Device Single Auditor Program (MDSAP) and In Vitro Diagnostic Device Regulations (IVDR) requirements
  • Lead role (administrative or technical) in one or more audits for review of a medical device manufacturers Quality Management System

 

About Our Organization

More Diagnostics, Inc. (MDI) is a well-established in vitro diagnostic device (IVDD) manufacturing company based in Los Osos, CA.  We have achieved an international reputation for developing reliable products that allow our clinical laboratory customers to obtain highly accurate test results.

“Quality, It’s Everything We Do” is a core value at More Diagnostics.  Doing things the right way without cutting corners is embedded in our culture. This position will be responsible for championing this value while ensuring compliance with applicable laws and regulations.

If you desire the opportunity to join a flexible and nimble business, based in the beautiful San Luis Obispo area, then keep reading.  The ideal candidate will have a strong regulatory and quality background a record of accomplishment in a quality driven environment.  Proven experience of success working in a small company culture is a must.