EVERGREEN REQUISITION - GLOBAL MDR SUBMISSIONS ANALYST II 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 II.
Hiring Location.
US Job Description Global MDR Analyst II is responsible for supporting medical device adverse event reporting within the complaint handling process.
This position is responsible for timely review, assessment of global complaints involving Olympus products, preparation, and submission of manufacturer / importer MDR reports in accordance with 21 CFR Part 803 Medical Device Reporting.
This role also supports performing follow-up/ good faith effort to obtain additional information for Adverse Events or reported event by collaborating with cross-functional and regional teams, Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly; Performs routine assignments with minimal direction from manager; requires general instruction for new or special assignments from Manager.
The Global MDR Analyst II will maintain quality documents to ensure compliance with  global medical device guidance documents.
This position requires working knowledge of medical device quality systems, FDA regulations relative to complaint handling and medical device reporting requirements including 21CFR820 and 21CFR CFR 806/ recalls, and quality systems (ISO ).
Job Duties Responsible for reviewing of complaint records and performing regulatory reporting assessments of global complaints, preparation and submission of manufacturer / importer MDR reports in accordance with 21 CFR Part 803.
Verify information including information available in ancillary systems data sources, as needed.
(For example.
Datasweep, SAP) Performs follow-up / good faith effort to obtain additional information for Adverse Events by collaborating with cross-functional, regional team, Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly.
Conducts timely initial MDR reportable assessment/ submission per 21CFR803.
Conducts timely re-assessments when new information has been received to determine if an initial or supplemental MDR is required Functions as a team member / leader or subject matter expert (SME) for MDR processes Under the direction of department management, is an active participant during internal and external audits or inspections Performs quality checks of complaints and/or medical device reports, as applicable Identifies opportunities for process improvement and waste removal.
Key Team player working closely with other Global MDR Submission Associates Perform other duties as assigned and appropriate Job Qualifications Required.
Bachelor of Science degree with 1-3 years medical device experience; OR   Associate degree with scientific discipline, or License Practical Nurse (LPN) with 3-5 years medical device experience (i.
.
LPN, Associate RN, X-Ray technician, Biomedical technician); OR   10 years or more medical device combined experience in post market surveillance, quality assurance, or complaint handling in lieu of a bachelor’s or associate degree.
Must be able to maintain good attendance regular scheduled hours.
Must be able to follow standard practices and procedures.
Attention to detail and accuracy required.
Strong analytical and organizational skills required.
Must be able to prioritize workload in order to meet regulatory/ procedural deadlines.
Basic knowledge of medical terminology and human anatomy.
Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO CFR820, 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.
Preferred.
Effective communication skills - both written and verbal English language.
Ability to effectively prioritize and manage workload.
Knowledge/ ability to utilize various software/database sources.
The ability to read, write and communicate effectively in English is required; includes clear, understandable speech and demonstrated comprehension skills.
The ability to collaborate and be a team player.
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.
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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Posting Notes.
|| United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)