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Working Location: Nationwide
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.
The Manager, Senior Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment and submission of 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, processing and submission of potential adverse events. The Manager, Sr. Global MDR Submission works closely with the Global COE MDR team, Market Quality, Legal Manufacturers, SBCs and other departments at the San Jose and Bartlett repair facilities and at the manufacturing sites in US and outside US. The Manager, Sr. Global MDR Submission communicates with the FDA or other interested internal and external parties as needed. This position will also provide MDR SME support for Market Quality as required in close collaboration with Olympus manufacturing sites and other Complaint Handling teams in other regions (Japan, EMEA etc.).
Required:
Why join Olympus?
Here, people matter—our health, our happiness, and our lives.
*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 .
The anticipated base pay range for this full-time position working at this location is $115,026.00 - $161,036.00 / 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 .
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 . If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus ).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
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