Global MDR Submission Manager
Olympus Medical Systems
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Field
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.
This position, the Manager of Global MDR Submissions, manages the Global MDR Submissions Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA and assisting with submissions to other regulatory agencies worldwide in conformance with applicable local, regional and international regulations. This position manages and directs these activities ensuring the timely review and processing of potential adverse events. The Global MDR Submissions Manager works closely with technical staff in Global MDR Submissions and other departments at the San Jose and Bartlett repair facilities and at the manufacturing sites. The Global MDR Submissions Manager communicates with the FDA or other interested internal and external parties as needed.
- Manage the daily operations of Global MDR Submissions Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA.
- Manage the daily operations of Global MDR Submissions Analysts who are responsible for overseeing and approving adverse event and vigilance reports associated with OSTA products sold or distributed internationally.
- Monitor complaint activities associated with OSTA products worldwide to ensure timely submissions in all markets.
- Work with local OSTA distributors as needed to resolve adverse event issues and assist with investigations.
- Establish Key Performance Indicators (KPIs) for the Global MDR Submissions Submission team to monitor internal processes and performance metrics necessary to ensure timely and uniform submissions.
- Work with QARA Management from throughout Olympus to improve and streamline processes and systems (e.g. EtQ, SAP, Datasweep, etc.) needed to support both local and global targets and objectives.
- Work with the Post-Market Surveillance department to establish tools and methods needed to monitor external sources of information such as media reports and clinical studies that may require complaint investigation or follow-up.
- Maintain all records associated with complaint and MDR submissions files necessary to maintain regulatory compliance, including lists and reports.
- Prepare other types of regulatory submissions to FDA and other interested external parties such s requests for additional information.
- Support audits of the complaint system conducted by FDA, MDSAP and all other external and internal parties.
- Perform other duties as required.
- Work experience must include a strong concentration in QSR compliance and complaint processing activities.
- Must have a minimum of 10 years combined experience in medical device complaint handling, medical device adverse event reporting and/or clinical experience.
- Clinical background strongly preferred.
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**
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.
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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||