Melissa Johnson Email & Phone Number

• Maintains strong working knowledge of FDA regulations, guidance documents, 93/42/ECC (MDD), EU 2017/745 (EU MDR), ISO14971,ISO13485, MDSAP, and other global regulatory requirements and standards
• Compiles electronic and paper materials required in regulatory submissions, license renewals and annual site registrations to FDA, Health Canada, India CDSCO, China CFDA, Taiwan TFDA and others
• Contributes as a team member in planning, developing, and implementing regulatory strategy throughout the medical device product lifecycle including product development processes and design control
• Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections
• Reviews and approves product data sheets, advertising, and other promotional materials
• Partners with cross-functional teams including production, document control, marketing, quality, and engineering to ensure regulatory requirements are met

• Developed and managed quality management system and quality personnel to achieve key performance indicators including on-time delivery, complaint rate and cost of poor quality
• Daily supervision and engagement with the QC inspection lab to ensure product realization commitments were met
• Managed and represented a quality management system that maintained quality registrations (ISO 13485, 21 CFR Part 820)
• Ensured quality engineers achieved agreed upon customer quality requirements through routine progress meetings
• Managed quality assurance team of nine (9) members and oversaw direct and indirect functions by coaching and mentoring to achieve business and quality objectives
• Actively promoted and drove a culture of safety

Salt Lake City, Utah, United States

• Supports the PharmaDx quality management System (QMS) to ensure its compliance with clinical diagnostic and medical device regulations
• Performs audits, gap assessments, and remediation activities in compliance with company quality management system (QMS) and regulatory requirements
• Acts as quality & regulatory representative on change controls, equipment validation plans and reports, and procedure deviations
• Approves nonconforming product investigations and CAPAs
• Operates as the primary point of contact with regulatory agencies and applicable authorized representatives
• Hosts US and international regulatory inspections

• Hosted onsite and remote external audits, inspections, and quality assessments by coordinating with multiple pharma sponsors and ARUP project managers
• Interpreted audit findings and prepared written responses for corrective actions and preventative actions
• Created internal department and supplier audit policies and procedures to ensured compliance to ISO 13485 and 21 CFR 820
• Reviewed and revised policies, processes, and procedures as they relate to quality and regulatory requirements within the PharmaDx group
• Conducted quality review of data, reports, and manufacturing batch records including issuance of statements of release
• Planned, coordinated, and completed internal audits of PharmaDx laboratory and ongoing sponsored projects

• Assisted in project initiation, organization, development, and testing of clinical trials and companion diagnostic devices
• Participated in audits, inspections, and quality assessments by project sponsors, FDA, and other certifying or regulatory bodies
• Worked in partnership with project stakeholders including technical operations, medical directors, finance, pharma sponsors, and quality management groups
• Wrote and revised clinical study standard operating procedures including protocols, verification and validation reports
• Prepared meeting agendas and led discussions on regular standing teleconferences with internal and external
• Collaborated with medical director and/ or primary investigators to create and manage IRB submissions

Greater Salt Lake City Area

• Manage 25+ orderable laboratory developed and FDA-approved tests in a CLIA-certified lab
• Work in partnership with quality assurance, document control, and education specialists to ensure support of company policies, marketing objectives, personnel engagement, and continuing education requirements
• Manage laboratory workflow, problem resolution, and promote positive morale of 32+ staff members
• Contact for clients, physicians, and business development managers for technical expertise and high-level problem resolution
• Manage multiple, complex projects by employing excellent multitasking and organizational skills
• Write and revise standard operating procedures, annual competency training documents and address gaps in knowledge to ensure the highest of quality results

Greater Salt Lake City Area

• Managed laboratory workflow of 12 staff that peformed FDA-approved, research use only, and laboratory developed testing in a CLIA-certified lab
• Reviewed quality control and quality assurance documentation for accuracy, identify concerning trends, and prepare comprehensive monthly laboratory reports based on findings
• Collaborated and effectively communicated information among a variety of departments to ensure uniform processes
• Participated in unannounced inspections and reviewed inspection reports and audits to ensure laboratory compliance to state, federal, and regulatory policies
• Conducted clinical molecular testing and provided high-level technical analysis of data to ensure accuracy and reliability of scientific findings
• Planned annual fiscal budget for operation of lab responsible for more than 12,000 billed units per month

• Assisted with department financial analysis, reporting, supply ordering and budgeting
• Answered client and lab staff questions regarding testing, methodologies, and instrumentation
• Prepared daily workflow schedule for 30+ member team on a weekly basis
• Reported laboratory status updates to group manager, division manager, and medical director
• Oversaw circulation of over 600 daily incoming samples to ensure smooth lab operation and seamless shift transitions employing strong oral and written communication skills
• Worked with focus and root-cause analysis groups to foster good communication, team morale, and improvement of laboratory processes

• Participated in specialized lab projects involving medical director and R&D collaboration
• Prepared specimens for processing and performed esoteric analytical processes
• Correlated and interpreted data based on knowledge of factors affecting test resultsby employing in-depth knowledge of techniques, principles, and instruments