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Global MDR Submission Lead

Req ID:  4918

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.

Job Description

This position provides leadership to the Global Analysts adverse event reporting within the complaint handling process. The Lead, Global MDR submission will review and approve MDR Reporting Decisions, Not MDR Reportable Rationales, and MDR Form 3500A content and submissions. This position requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806 and 21CRF803. An understanding of global adverse event reporting criteria (For example: Europe, China, Australia, Latin America, Japan, and others) is highly preferred.

 

The lead will not have any direct reports however will be a strong mentor, assist in training, and provide feedback Global MDR Submission Analysts and ensure that the department activities are performed in conformance with US Food and Drug Administration Quality System Requirements (QSR) and company policies and procedures.

Job Duties

* Collaboration with Managers, MDR Global Submissions and other departments as required.

 

* Assist in daily assignments.

 

* Review and Approve MDR Form 3500A Submissions and reportable rationales.

 

* Ensure timely and Quality MDR submission.

 

* Assist in identifying challenges and recommendations for process efficiencies in the MDR submissions.

 

* Perform other duties as assigned.

Job Requirements

PREFERRED QUALIFICATIONS:

 

* Bachelor of Science degree or related Certification/Licensure in Nursing, Biomedical Engineering,

 

* Minimum of 3-5+ years MDR medical device industry.

 

* Up to 5% domestic travel

 

* Interfaces with customer for follow up information related to complaint and product return requests.

 

* Maybe required to work outside of normal business hours to accommodate Global Corporation.

 

#LI-JG

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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

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 || 


Nearest Major Market: Memphis

Job Segment: Biomedical Engineering, QA, Quality Assurance, Engineer, Engineering, Quality, Technology

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