Lucira Health
  • Vista, CA, USA
  • Full Time

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative infectious disease test kits. We have developed a testing platform that produces centralized-laboratory-accurate molecular testing in a single-use and consumer-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. Our LUCIRA Check It (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

Location

Vista, CA - Flexible work from home schedule

Summary

The Senior Manager of Regulatory Compliance will lead the overall compliance program and will ensure the company meets all regulatory obligations. This position will drive the necessary activities to ensure continual compliance that supports the company growth and success.

Responsibilities

  • Leads the establishment, planning, execution and maintenance of regulatory compliance programs for Lucira Health, coordinates with other functions to perform periodic internal audits
  • Works in conjunction with Quality Management Systems, develops integrated planning and support for all external inspections and audits
  • Drives critical compliance improvement initiatives identified through audit, CAPA, management review and other input sources
  • Provides reports to executive leadership on key compliance opportunities and risks
  • Provides expert guidance and supports all Lucira functions to ensure a compliant establishment of quality system processes to meet applicable regulations
  • Provides regulatory support to labeling design and implementation to ensure compliance with applicable regulatory standards
  • Leads in the establishment of compliant processes and procedures for regulatory requirements, including MDSAP, IVDR, and others as applicable
  • Leads the company vigilance programs, including on-time submission of adverse event reports (e.g. MDR, MIR) and global field action programs
  • Supports Regulatory Affairs projects as assigned, including regulatory submissions, and amendments
  • Provides company training on quality system regulations, including FDA 21 CFR 820 and ISO standards including ISO 13485, ISO 14971, and other standards as applicable
  • Utilizes problem solving methodologies including Six Sigma, Lean Principles and root cause analysis to investigate
  • Performs other duties as assigned

Qualifications

  • B.S. degree in Biomedical or Engineering or related discipline
  • 10+ years of medical device experience in a quality system compliance role
  • Experience with software, reagents, and assay development, design control processes preferred
  • Demonstrated experience in representing the company during FDA Inspections
  • Familiar with the MS Office Suite

Lucira Health is an equal opportunity employer and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or any other consideration made unlawful by federal, state or local law.

Lucira Health
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