Job Description

POSITION: HEALTH AUTHORITY REPORTING ANALYST LOCATION: IRVINE, CA USA 92618 DURATION: 11 MONTHS DESCRIPTION:

• This job description covers the purpose, responsibilities, skill sets, and associated training and education required for the Health Authority Reporting Specialist.
• The purpose of the Health Authority Reporting Specialist is to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support.
• Focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1, Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.
• Duties & Responsibilities may vary depending on the Operating Company the individual is assigned to.

DUTIES AND RESPONSIBILITIES:

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position will:
• Demonstrate world class customer support and maintain knowledge of relevant Operating Company’s products and services
• Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include assigning product experience and patient codes. Utilize MD Workflow reports to identify tasks and manage common Email inboxes
• Make regulatory reporting determinations on applicable files for one or more Business Units.
• Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint files activities.
• File Medwatch report forms within required timelines as applicable
• File MDVs in accordance to EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable
• Create and/or forward additional information follow up questions as part of complaint investigation.
• Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management
• Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process
• Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable
• Manage Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicable
• Supporting regulatory additional information requests and actively supporting compliance audits
• Participate in audit and compliance review processes as needed
• Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures
• Participate in assigned projects towards desired business outcomes
• Participate in the onboarding training of new associates and/or existing associates learning a new product
• Participate in escalation process as required
• Partnering and influencing with stakeholders both internally and externally to drive needed change and/or execution of complaint related matters
• Be responsible for communicating business related issues or opportunities to next management level
• Be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Perform other duties assigned as needed

EXPERIENCE AND EDUCATION:

• Completed apprenticeship or Baccalaureate degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/Bachelor’s Degree or equivalent experience
• 2-4 Years related experience is desirable (A combination of experience and education can be allowed)
• Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements
• Knowledge of human anatomy, medical terminology and products of applicable Business Units

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATION/LICENSES

• Strong written and verbal communication skills.
• Fluent spoken/written English required.
• Strong decision-making skills – able to make sound business decisions with sometimes limited information
• Ability to work in a cross-functional and matrix environment
• Ability to work independently
• Continuous Improvement focus
• Time management.
• Ability to handle multiple priorities/ sudden changes in priorities
• Ability to work in stressful/fast paced environment
• Ability to work and interact with co-workers to accomplish company goals in a team environment
• Analytical/Problem Solving Skills
• Ability to learn
• Strong attention to detail

COMPUTER SKILLS:

• PC computer skills, MS Windows, MS Office (MS Outlook, Word, Excel, PowerPoint) and other communication tools such as Microsoft Teams, Skype, Zoom etc.

Company Description

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.