Olympus Corporation · 1 day ago
Global MDR Submissions Analyst III
Center Valley, PA
Full-time
Onsite
Mid, Senior Level
$78K/yr - $105K/yr
3+ years expOlympus Corporation is a global medical technology company dedicated to improving patient outcomes through advanced medical technologies. They are seeking a Global MDR Submissions Analyst III who will be responsible for reviewing and coordinating the resolution of complex medical device complaints, ensuring compliance with FDA regulations and reporting requirements.
ElectronicsIndustrialManufacturingMedical DeviceProduct Design
Responsibilities
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)
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
Qualification
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
Benefits
Competitive salaries, annual bonus and 401(k) with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center
Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
Company
Olympus Corporation
Olympus is passionate about creating customer-driven solutions for the medical industry.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Yasuo Takeuchi
Executive Chairman
Recent News
2025-05-27
2025-05-19
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