Irvine, CA

November 3, 2020

Location: Irvine, CA

Department: Regulatory Affairs & Quality Assurance

Reports To: Global VP, Regulatory Affairs and Quality

FLSA Status: Exempt

 

AIM OF THE POSITION

The Director, QA/RA will be responsible for monitoring and maintaining the Quality Management System in compliance with the corporate Quality Policy, corporate and department goals and objectives and external regulations including US FDA Quality System Regulations (QSRs), CLIA, ISO 13485 and other worldwide in vitro diagnostic device regulatory requirements as appropriate.  Management Representative responsible for establishing, maintaining, improving and reporting the status of the Quality System.

POSITION WITHIN THE ORGANIZATION

  1. Conducts annual Management Review [chair]
  2. Conducts monthly QA corporate KPI meetings [chair]
  3. Department meetings [participant]
  4. Working groups [participant/chair]
  5. Participates in internal and external regulatory audits [participant/lead]

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develops and enhances Quality Management System and ensures full audit-readiness for Agendia, Inc. and Agendia NV.
  • Oversees Customer Complaint handling function to ensure proper and timely complaint handling, root cause identification, and complaint closure. Monitors complaint review and trend analysis.
  • Responsible for post-market surveillance and vigilance reporting for product incidents to all approved markets.
  • Provides advice on regulatory requirements and prepares regulatory submissions
  • Support Global VP of RA/QA in developing and influencing domestic and international regulatory policies.
  • Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring regulatory approval.
  • Prepare reports for FDA or other international agencies as required.
  • Defines, implements and directs quality activities for new product development including adherence to Design Controls procedures.
  • Provides support to manufacturing in proactive resolution of quality issues, root cause failure analysis and troubleshooting.
  • Oversees all aspects of Supplier Quality controls.
  • Works proactively with the laboratory Operations staff to identify and correct quality problems with products and processes.
  • Manages facilities inspections by state, federal and international regulatory agencies, specifically California Department of Health Services, US federal FDA, ISO, CAP, CLIA.
  • Review and approve labeling/marketing materials for compliance with applicable regulations and standards.
  • Review new and existing regulations, guidance documents and standards and prepares comments based on impact to new and existing products and business.
  • Manages performance of staff towards department and company goals, including feedback on performance.
  • Co-develops and maintains department expense budgets in support of the annual Business Plan
  • Performs other related duties as required or assigned

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 agencies
  • Experience with State Clinical Boards and/or the College of American Pathologists (CAP), is preferred

EDUCATION & EXPERIENCE REQUIREMENTS:

EDUCATION

  • Requires a Bachelor’s degree in life science or related discipline or a combination of equivalent work experience and education.

EXPERIENCE

  • 10+ years overall working experience, with at least 5+ years direct QA or RA experience.
  • In vitro diagnostic or molecular reagent quality assurance, document control, configuration management, supply chain, operations, and/or quality departments within a regulated environment, preferred.

KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)

Knowledge: Comprehension of a body of information acquired by experience or study.

Skill: A present, observable competence to perform a learned activity.

Ability: Competence to perform an observable behavior.

  • Deep experience with regulatory submissions and compliance processes as related to medical devices for both US and global markets.
  • Good working knowledge of IVD/Medical Device Regulations, standards, submission, Technical Documentation and CE certification (ISO 13485, IVDD/IVDR and 21 CFR Part 820).
  • Good working knowledge of FDA regulations concerning device submissions.
  • Experience in regulatory audits, ISO certification, GxP requirements (such as GDP, GMP, GLP).
  • Experience understanding and applying quality system regulations and standards, including GDP, CLIA, CAP, ISO 13485 and/or 21 CFR Part 820
  • Excellent problem solving and analytical skills
  • Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
  • Experience in MS Word, Excel, and PowerPoint required
  • Experience with delivering training material to groups
  • Must be team oriented and have effective communication skills to work as part of a team Experience in supporting and guiding ISO/FDA inspections is strongly preferred
  • Proven experience with training in auditing and in CAPAs (Corrective and Preventive Actions) preferred
  • Molecular biology/diagnostics experience/software validation are a plus
  • ASQ Certification in CBA or CQA desired

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

  • Able to prioritize and plan work activities, use time efficiently and develop realistic action plans with detailed follow through.
  • Willing to make decisions, exhibit sound and accurate judgment, and make timely decisions for the result with limited direction.
  • Ability teach technical aspects of regulatory compliance and lead teams in problem solving.
  • Must have the ability to work as a team player within all levels of the company.
  • Ability to effectively communicate with individuals and groups across interdisciplinary roles.
  • Able to develop and maintain relationships across departmental boundaries.
  • Ability to read and interpret regulations

WORKING ENVIRONMENT

  • Established ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

  • Working conditions (inside or outside the office).
    • General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL

Ability to travel to meet territorial requirements of us to <10%

OTHER DUTIES

Other duties as required by management