at Olympus Corporation of the Americas in Bartlett, Tennessee, United States
Working Location: TENNESSEE, BARTLETT
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.
Let’s inspire healthier lives, together.
As a Global MDR Submission Analyst II OSTA team member, you will be responsible for timely regulatory reporting assessments and reassessments of global complaints, preparation and submission of initial /supplemental/ importer MDR reports for post market activities per 21CFR803. Perform follow-up to obtain additional information for Adverse Events by collaborating with 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. This position will be able to speak and read Japanese. The Analyst II will maintain quality documents to ensure compliance with global medical device guidance documents. The Analyst II requires working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803. This is a field/remote position and there are multiple openings available.
- Review incoming complaints to determine the facts of the case.
- Be able to speak and read Japanese.
- Verify information including information available in ancillary systems data sources. (For example: Datasweep, SAP)
- Performs follow-up to obtain additional information for Adverse Events by collaborating with 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 per 21CFR803.
- Assist with preparation and submission of FDA Additional Information responses, and associated documentation to the FDA and Manufacturing Business Centers (MBCs).
- Assist Global MDR Submission Management in the successful identification and resolution of quality issues associated with complaints.
- Key Team player working closely with other Global MDR Submission Associates.
- Perform other duties as assigned.
- Bachelor of Science degree with a minimum of 1-3 years medical device experience or Associate degree with scientific discipline, with 3-5 years medical device experience. (i.e. Associate RN, X-Ray technician, Biomedical technician)
- Effective communication skills – written and verbal in Japanese language.
- Attention to detail and accuracy required.
- Complaint Handling/ Customer Service experience in the Medical Device/ Pharmaceutical 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 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.
- 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.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks – so you can be ready for where life can take you.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com .
Olympus…True To You. True To Society. True To LIFE.
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.
Posting Notes: || United States (US) || Tennessee (US-TN) || Bartlett ||
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