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 .

The anticipated base pay range for this full-time position working at this location is $86,968.00 - $117,406.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

About us:

Our 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 costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 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 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

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.

Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)