Senior Manager, Market Quality- MDR - Olympus Corporation of the Americas
San Francisco, CA
About the Job
Working Location: California, San Francisco
Workplace Flexibility: Field
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
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.).
Job Duties
+ Manage the daily operations of the COE MDR Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA for all products manufactured or distributed by Olympus entities for events that occur in the United States (US) and for events that occur globally where Olympus has regulatory responsibility for US medical device reporting requirement.
+ Work with Olympus legal manufacturers and Service Centers as needed to resolve adverse event issues and assist with complaints investigations.
+ Establish Key Performance Indicators (KPIs) for the Market Quality COE MDR team to monitor internal processes and performance metrics necessary to ensure timely and uniform submissions. Responsible for developing and monitoring tools and provide inputs to Management Reviews where required.
+ 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 MDR reporting.
+ 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 as requests for additional information.
+ Support audits of the complaint system and quality processes conducted by FDA, MDSAP and all other external and internal parties.
Job Qualifications
Required:
+ Bachelor of Science, medical, engineering, or scientific discipline.
+ Minimum of 10 years management level experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR ) compliance and quality assurance.
+ Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
+ Demonstrated experience in developing and leading a top performing Quality team is required.
+ Proficient understanding of medical device regulations both domestic and international with specific expertise in; Internal and External audits, Regulator Inspections, Complaints and Regulatory reporting, US FDA Regulations ( 21 CFR Parts 803, 820, 806) and Corrective and Preventive Actions (CAPA).
+ Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.
+ Up to 10% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
The anticipated base pay range for this full-time position working at this location is $116,751.00 - $163,452.00 / 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.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
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) || California (US-CA) || San Francisco || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Field
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
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.).
Job Duties
+ Manage the daily operations of the COE MDR Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA for all products manufactured or distributed by Olympus entities for events that occur in the United States (US) and for events that occur globally where Olympus has regulatory responsibility for US medical device reporting requirement.
+ Work with Olympus legal manufacturers and Service Centers as needed to resolve adverse event issues and assist with complaints investigations.
+ Establish Key Performance Indicators (KPIs) for the Market Quality COE MDR team to monitor internal processes and performance metrics necessary to ensure timely and uniform submissions. Responsible for developing and monitoring tools and provide inputs to Management Reviews where required.
+ 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 MDR reporting.
+ 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 as requests for additional information.
+ Support audits of the complaint system and quality processes conducted by FDA, MDSAP and all other external and internal parties.
Job Qualifications
Required:
+ Bachelor of Science, medical, engineering, or scientific discipline.
+ Minimum of 10 years management level experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR ) compliance and quality assurance.
+ Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
+ Demonstrated experience in developing and leading a top performing Quality team is required.
+ Proficient understanding of medical device regulations both domestic and international with specific expertise in; Internal and External audits, Regulator Inspections, Complaints and Regulatory reporting, US FDA Regulations ( 21 CFR Parts 803, 820, 806) and Corrective and Preventive Actions (CAPA).
+ Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.
+ Up to 10% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
The anticipated base pay range for this full-time position working at this location is $116,751.00 - $163,452.00 / 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.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
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) || California (US-CA) || San Francisco || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas