EVERGREEN REQUISITION - GLOBAL MDR SUBMISSIONS ANALYST III JOB DETAILS | OLYMPUS CORPORATION OF THE AMERICAS

Working Location.
NATIONWIDE   Workplace Flexibility.
Field   For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
​ ​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
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Patient Focus, Integrity, Innovation, Impact and Empathy.
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*    Olympus is looking for Global MDR Submissions Analyst III.
Hiring Location.
US   Job Description As a Global MDR Submission Analyst III OSTA team member, you will be 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 ISOCFRCFR806 and 21CRF803 and will also have a an understanding of global adverse event reporting criteria (For example.
Europe, China, Australia, Latin America, Japan, and others).
The Analyst III assists with reportable determinations for OSTA products 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.
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.
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.
Acts as a resource for department staff members on complex complaints.
Completes Clinical Assessments for complex cases and upon request, when appropriate.
Prepares and reviews MDRs/Supplemental reports for the FDA for complex complaints Monitors progress of all ongoing complaint activities and MDRs to ensure the timely submissions.
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.
Other duties as assigned Job Qualifications Required.
Bachelor of Science degree with Certification/ Licensure in Nursing, Biomedical Engineering, Risk Management and 3- 5 years medical device experience or Bachelor of Science degree with 5 or more years of medical device experience including adverse event reporting.
Complaint Handling/ Customer Service experience in the Medical Device/ Pharmaceutical required.
Effective communication skills - both written and verbal English language.
Ability to effectively prioritize and manage workload.
Ability to quickly adapt to various software/ database interfaces and basic functions.
Why join Olympus?   We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on.
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**   Connected Culture you can embrace.
Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Diversity Equity & Inclusion Initiatives including Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance   *US Only   **Center Valley, PA and Westborough, MA     Are you ready to be a part of our team?   Learn more about our benefit and incentives.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling.
As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than employees worldwide in nearly 40 countries and regions.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than employees throughout locations in North and South America.
For more information, visit www.
lympusamerica.
om.
Olympus is dedicated to building a diverse, inclusive and authentic workplace   We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.
We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
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As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone.
If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at .
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Posting Notes.
|| United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)