Irvine, CA

December 3, 2020

Location: Irvine, CA or Remote

Department: Sales

Reports To: Regional Sales Director

FLSA Status: Exempt

AIM OF THE POSITION

The Global Manager, Quality and Regulatory Compliance supports and maintains the quality systems program to ensure compliance with all the regulatory affairs and quality systems requirements throughout Agendia.

POSITION WITHIN THE ORGANIZATION

1.       Reports to Director, Quality and Regulatory Affairs

2.       Cooperates with all departments across the organization

3.       Organizes activities within the QA/RA Department

4.       Participates in:

  • Department meetings (local)
  • Meetings with Internal and External Stakeholders – Amsterdam site, vendors, suppliers
  • Project meetings
  • Working groups
  • Project groups

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensure continued compliance with Agendia, FDA’s QSR, ISO 13485, IVDD/IVDR, CLIA, CAP and other regulatory agency requirements for In vitro Diagnostics and Laboratory products.  These include the maintenance of the quality system and collaborate in changes to the quality system and changes that affect the quality system.
    • Ensures applicable standards and regulations pertinent to Agendia are effectively implemented and acts as an advisor to all managers.
  • Coordinate NCMR and ASL activities. Develop systems for the identification, analysis, prevention and correction of quality issues.
    • Coordinate Quality Plan activities and Quality Management Review process. Collaborate with management team in development, and execution of goals, objectives and projects. Support initiatives to ensure effective reporting of quality systems metrics.
    • Lead Complaint Handling activities including investigation, escalation and reporting requirements as needed Coordinates Post-market surveillance and vigilance reporting for product incidents to all approved markets.
    • Lead internal audit and CAPA processes to ensure the processes add value through effective implementation of root cause analysis.
  • Coordinate Quality Plan activities and Quality Management Review process. Collaborate with management team in development, and execution of goals, objectives and projects. Support initiatives to ensure effective reporting of quality systems metrics.
  • Maintain domestic and international certifications and registrations.
  • Support internal and external audits to ensure continued compliance with all applicable regulations. This includes preparation of an audit schedule, conducting audits, preparing and distributing reports, follow-up activities for corrective actions, maintenance of internal and external audit files and distribution of status reports to management.
  • Support nonconformance and CAPA activities; identification of root causes and implementation of corrective actions for audit findings and CAPAs. Support CAPA review meetings and assist following-up on open action items until closure.
    • Support the training program for the training of employees on Quality System Regulations and standards.
    • Assist in Regulatory Affairs submissions by reviewing files and compiling documents as needed for regulatory agencies and Notified Body.
    • Assist in the identification of regulatory requirements for new products and changes to existing products, for example: labeling, design, equipment, process changes
    • Assist in continuous improvement activities throughout the organization by utilizing quality system expertise. Assist NCMR and ASL activities.
    • Collaborate with local management team members in developing long and short-term business goals and strategies.
  • The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

KEY CONTACTS

Internal:

Works closely with:

  • All levels of the organization and works especially close with the laboratory operations and department directors in R&D, Product Support, Clinical, Marketing, and IT. This position has interactions with all departments company wide

External:

Works closely with:

  • Vendors and regulatory agencies, such as the FDA, ISO Notified Bodies other global regulatory agents
  • Experience with State Clinical Boards and/or the College of American Pathologists (CAP), is preferred

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

Preferred:

  • Degree in Science Related Field
  • Internal Audit Certification
  • Regulatory Affairs Certification
  • Knowledge in the application of risk management

EXPERIENCE

  • 5-7 years of experience in a regulated environment, preferably IVD, Medical Device or Laboratory

KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)

  • Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations (US and International)
  • Knowledge of with IVD, medical devices, CAP, CLIA requirements
  • Knowledge in Lab environment or biological field requirements
  • Knowledge in database management applications

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

  • Time management skills
  • Effective oral and written communication skills
  • Effective interpersonal skills
  • Ability to multi-task
  • Problem solving skills
  • Facilitation and training skills

WORKING ENVIRONMENT

  • Established ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

  • Vision to read written and published quality documents and to observe operations
  • Must be able to stand / walk / sit up to 8 hours a day

TRAVEL

  • <10% Travel