Global MDR Submission Analyst III

Working Location: MASSACHUSETTS, SOUTHBOROUGH 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

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 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?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

 

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

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