Regulatory Specialist

Quality Assurance San Francisco, California


Description

Spire Health is seeking a Regulatory Specialist. The Regulatory Specialist is responsible for providing subject matter expertise in Post Market Quality activities such as Complaint Handling, MDR and Vigilance reporting, trending and monitoring.

Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports complaint handling in internal and external audits and inspections. Complaint handling will comprise roughly 50% of the role.

Responsibilities:

  • Provide input, guidance, training and administrative support regarding complaint and regulatory reporting across the organization
  • Support systems and processes that Post Market Quality requires to manage complaints, reporting and other related processes in ISO 13485, US 510(k) regulated environment
  • Identify gaps in the complaint handling process, recommend solutions and support implementation of corrective actions to ensure continued compliance with applicable regulations
  • Ensure complaint investigations are adequate, accurate, detailed and timely
  • Analyze quality data and events reported from multiple inputs to determine complaint status and regulatory reportability
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility 
  • Assist in field action activities as needed
  • Participate as the Post Market Quality representative on other projects as requested
  • Other tasks to support the Post Market Quality team in successful and timely complaint management and regulatory reporting
  • Identify, generate and publish metrics and reports related to complaint information 
  • Perform other duties as assigned

Qualifications:

  • Bachelor degree or higher technical or science degree
  • Minimum 1 year relevant quality, regulatory, or compliance experience working in a medical device company, regulated environment or equivalent   
  • Knowledge and experience with medical device complaint handling computerized systems
  • Ability to independently analyze various forms of quality data and provide actionable output
  • Independent thinker, willing to present alternative conclusions or inferences 
  • Strong computer skills, particularly with Excel and the ability to learn new applications; Microsoft Office Suite 
  • Good interpersonal skills and able to work well with cross-functional teams  
  • Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting
  • Must be self-directed with the ability to work independently with minimal supervision