Evergreen Requisition - Global MDR Submission Analyst III - Hybrid

Working Location: MASSACHUSETTS, WESTBOROUGH 

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Olympus is looking for a Global MDR Submission Analyst III.

Hiring Location: Westborough, Massachusetts

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 ISO13485, 21CFR820, 21CFR806 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 Requirements

REQUIRED QUALIFICATIONS:

* Bachelor of Science degree with Certification/ Licensure in Nursing, Biomedical Engineering, Risk Management, minimum of 3 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.

PREFERRED QUALIFICATIONS:

* 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.

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) || Massachusetts (US-MA) || Westborough ||