IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR). Based on the position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary.

PURPOSE OF JOB: 

Regulatory Affairs (Associate / Specialist / Senior Specialist) Post Market Surveillance personnel are responsible for:

(1) analyzing Post Market Surveillance (PMS) data to prepare Post Market Surveillance reports and documentation, and to update related risk and other documentation accordingly

(2) assessing Adverse Events to determine reportability and performing reporting to governments/agencies/distributors accordingly

(3) ensuring that communications, complaints, and other feedback regarding Iridex products and services are investigated, evaluated, and, as necessary, internally addressed and/or reported to external agencies.

This position will interact directly with cross functional Iridex personnel as well as product distributors, product users, and feedback source(s)/complainant(s).

This position may directly interact with regulatory authorities

MAJOR DUTIES AND RESPONSIBILITIES:

• Analyze Post Market Surveillance (PMS) Data to Prepare Post Market Surveillance Documentation
  • Prepare, Review, Obtain Post Market Surveillance Data
    • Analyze Complaint Data, including AE and SAE data and resultant CAPAs
    • Analyze Data from Publicly Available AE Databases
    • Perform a review of Published Scientific Literature, including literature searches
    • Perform a review of Clinical Investigation Databases
    • Work with Marketing to perform a Survey of User Market-related Experience
  • Prepare/Revise/Update Post Market Surveillance Reports, consistent with external guidance and requirements, and Iridex-internal procedures and plans, including:
    • Post Market Surveillance Plan (PMSP)
    • Post Market Surveillance Report (PMSR)
    • Post Market Surveillance Update Report (PSUR)
    • Post Market Clinical Follow Up Plan (PMCF Plan)
    • Post Market Clinical Follow Up Report (PMCF Report)
    • Clinical Evaluation Plan (CEP)
    • Clinical Evaluation Report (CER)
• Assess Adverse Events to determine reportability and report to Governments/agencies/distributors accordingly
  • Perform and Document Adverse Events (AEs) and Serious Adverse Events (SAEs) reportability assessment
  • Perform AE and SAE reporting and related communication
• Perform and document Complaint Handling, assessment, and reporting
  • Receive and investigate product- and service-related communications / complaints, with communication received from various sources, including communications from field service management platforms (ServiceMax), customer relationship management platforms (SalesForce), enterprise resource planning platforms (Business Central), internal service records, and other direct and indirect customer/user communications.
  • Document the complaint evaluation activities within the Product Lifecycle Management (PLM) tool (RitePro), including complaint evaluations, investigations, and assessment for reportability.
  • Communicate with feedback source/complainant regarding complaint investigation, status, and to obtain necessary data/information.
  • Work closely with Technical Services, R&D / Engineering, Quality Assurance, Clinical and Marketing personnel to coordinate review of complaints
• Provide Complaint and other PMS information/Data to Internal Iridex personnel
  • Perform, Prepare, and Present Complaint Summaries
    • Quarterly Trending
    • Annual Trending
  • Provide investigation results to cross functional teams to allow internal response to identified trends/issues
  • Initiate update of various Engineering documentation, including risk management documentation, to reflect PMS/Complaint data.

LEVEL DIFFERENTIATION:

• Associate: Work is closely managed. Works on projects/matters which may have limited complexity and/or works in a support role.
• Specialist: Occasionally directed in several aspects of the work. Gaining exposure to complex projects
• Senior Specialist: Work is generally independent and collaborative. May assume a team lead for a work group.

QUALIFICATIONS:

• Education: Bachelor’s degree, advanced degree preferred (Engineering or Clinical degree preferred) OR 4-years of relevant experience in Regulatory Affairs in the medical device industry
• Experience:
  • Associate: Typically requires 0 - 3 years of related experience (e.g., regulatory affairs, quality systems/assurance, etc.) in the medical device industry
  • Specialist: Typically requires 4 - 6 years of regulatory affairs experience in the medical device industry
  • Senior Specialist: Typically requires 6+ years of regulatory affairs experience in the medical device industry
• Computer literate and proficient in Microsoft Office Suite and Adobe Acrobat.
• Excellent oral and written communication skills
• Ability to maintain confidentiality of information and materials.

ADDITIONAL INFORMATION:

• Department: Regulatory Affairs
• Reports To: Director, Regulatory Affairs
• FLSA Status: Exempt
• Annual Base Salary: $75,000 - $95,000 (DoE)
• Work Location: 100% onsite in Mountain View, CA