Global MDR Submission Analyst III

Job Description

Responsible for the review of medical device global complaints and coordinate the resolution of complex complaints (For example: death, serious injury, legal papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806 and 21CRF803 and will also have an understanding of global adverse event reporting criteria (For example: Europe, China, Australia, Latin America, Japan, and others). The Analyst III is responsible for determining medical device reportability for Olympus products or products for which Olympus has contractual obligations, and performs clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is required. Supports and may represent the Medical Device Reporting Process in internal and external audits. Prepares responses to standard requests from a regulator, as needed. Supports due diligence process in obtaining information cross-functional and external to Olympus. Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and mentors lower-level staff; initiates new or special assignments with occasional direction from Manager. Must have ability to work in a team environment and be self-motivated and organized.

Job Duties

• A seasoned, experienced professional with a full understanding of complaint handling.
• Reviews complex complaints such as death, serious injury, legal papers, and literature reviews for medical devices independently. Ensures complaint files have an appropriate resolution and/or justification.
• Responsible for assessing complaints, completing decision trees, and documenting reportability in the system in a consistent and timely manner in accordance with 21 CFR Part 803 Medical Device Reporting.
• Prepares and reviews MDRs/Importer/Supplemental reports for the FDA for complex complaints.
• Responsible for the coordination of complaint related tasks with other cross-functional team members and the local RA/QA representatives for countries outside of the US and ensuring reportability decisions are made and reports are filed in a timely manner.
• This position may interact with internal and external customers, sales organization, local RA/QA representatives, healthcare providers, nurses, patients as well as external regulatory bodies, such as US FDA and notified body, concerning products issues, product information, patient requests and complaints and contributes to the preparation of responses to standard requests and extended requests from Regulatory Bodies.
• Acts as a resource for department staff members on complex complaints.
• Completes Clinical Assessments for complex cases and upon request, when appropriate.
• Monitors progress of all ongoing complaint activities and MDRs to ensure the timely submissions.
• Documents and maintains records of adverse events reports in accordance with internal procedures and applicable regulatory requirements. Completes all required customer complaint/adverse event related documentation in an accurate, professional and timely manner.
• May also be asked to represent and support the Medical Device Reporting Process in internal and external audits.
• Provides training during orientation and on-boarding of new staff. Mentors staff members regarding complaint processing.
• May provide assistance to junior level staff with general tasks that require a better understanding.
• Processes reportability decisions and is able to complete MDR submissions.
• Assist in the preparation of regulatory body additional information requests. Functions as a team member/ leader in collaboration.
• Lead/Manage special assignments/ projects with Global MDR Submission or across functional areas.
• Must have ability to work in a team environment and be self-motivated and organized.
• Other duties as assigned.

Job Qualifications

Required:

• Bachelor of Science degree, or Associate of Science and Licensure in Nursing from an accredited college or university Bachelor of Science degree in any of the relevant scientific discipline.
• A minimum of 3 years of experience on the healthcare/clinical setting or other points of care; OR
• An equivalent combination of 3-5 years medical device and clinical experience.
• Must possess excellent verbal and written communication skills.
• Able to consistently meet deadlines despite high volume.
• Able to work under pressure.
• Strong feeling for Accountability.
• Strong critical thinking, communication, problem-solving skills, and detail oriented.
• Basic knowledge of medical terminology and human anatomy.

Preferred:

• A minimum of 3 years of related experience on the medical device industry with attention to complaint handling and adverse event reporting and/or post-market surveillance organization strongly preferred.
• The ability to read, write and communicate effectively in English is required; includes clear, understandable speech and demonstrated comprehension skills.
• Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications.
• Ability to effectively prioritize and manage workload.
• Organization, prioritization, and familiarity with working in a regulated industry setting.
• Competency in computer software/hardware will also be useful in resolving or elevating IT concerns and issues.
• Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
• Experience with utilization of TrackWise or ETQ preferred.
• Knowledge/ability to utilize various software/ database sources.
• Must be able to maintain good attendance regular scheduled hours.
• Must be able to follow standard practices and procedures.
• Attention to detail and accuracy.
• Strong analytical and organizational skills.
• Must be able to prioritize workload in order to meet regulatory/ procedural deadlines.
• Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.
• Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
• Follows standard practices and procedures in analyzing situations or data from which answers can be obtained.