Irvine, CA

December 3, 2020

Location: Irvine, CA or Remote

Department: Regulatory Affairs & Quality Assurance

Reports To: Global Manager, QA & Compliance

FLSA Status: Exempt

AIM OF THE POSITION

The Quality and Regulatory Compliance Specialist 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 QA/RA

2. Cooperates with all departments across the organization

3. Participates in:

  • Department meetings
  • FDA/Notified Body inspections or audits by College of American Pathology (CAP)
  •  Corporate projects, as appropriate

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.
  • Support development of regulatory submissions
  • Provide support to currently marketed products as necessary: labeling, product changes/documentation.
  • Coordinate initiatives to support quality systems, IVDR and continuous improvement efforts.
  • 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.
  • Lead internal audit and CAPA processes to ensure the processes add value through effective implementation of root cause analysis.
  • 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 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.
  • Review regulatory affairs documents and compile documentation for regulatory agencies and Notified Body.
  • Assist in continuous improvement activities throughout the organization by utilizing quality system expertise.
  • 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:

o   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:

  • 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

  • In vitro diagnostic or molecular reagent quality assurance, document control, configuration management, supply chain, operations, and/or quality departments within a regulated environment, preferred.
  • 5-7 years of direct work experience in QA, including all aspects of device/diagnostic quality systems
  • Bachelor’s Degree in Molecular Biology or related field plus 5 years of industry experience; in vitro diagnostic or molecular reagent quality assurance preferred

KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)

  • 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 official (external) training in auditing and in CAPA’s (Corrective and Preventive Actions) preferred
  • Molecular biology or diagnostics experience is a plus
  • ASQ Certification in CBA or CQA desired

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

  • <10% Travel