Global Regulatory Affairs Operations Manager - Olympus Corporation of the Americas
Center Valley, PA
About the Job
Working Location: NATIONWIDE
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 Global Regulatory Affairs Operations Manager, is responsible for overseeing and managing high-impact QARA (Quality and Regulatory) projects and initiatives, ensuring timely completion and adherence to objectives. The Operations Manager will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth and efficient delivery of QARA programs and goals. This role requires a proactive leader with exceptional organizational, analytical, and interpersonal skills who can manage multiple projects and priorities simultaneously.
Job Duties
+ Support the VP of Global Regulatory Affairs Operations in strategic planning and execution.
+ Provide data-driven insights and recommendations to inform strategic decisions.
+ Assist in the development and implementation of departmental goals.
+ Lead and manage regulatory projects, ensuring timely and successful completion.
+ Coordinate with cross-functional teams to ensure alignment and support for Regulatory initiatives.
+ Track project progress, manage timelines, and report on project status to senior management.
+ Identify areas for improvement and implement process optimization initiatives.
+ Prepare and follow up on meetings, including interdepartmental and company-wide initiatives, ensuring preparedness and proper execution.
+ Foster a collaborative and high performing culture within the team.
+ Maintain up-to-date knowledge of relevant regulations, guidelines, and industry trends.
+ Collaborate with internal and external stakeholders to ensure alignment and proper support for Regulatory and Quality initiatives.
+ Act as a liaison between the Regulatory Affairs department and other departments within the organization.
+ Represent the department in meetings, presenting updates and advocating for Regulatory priorities.
+ Monitor organizational KPIs to ensure efficiency and quality of tasks.
Job Qualifications
Required:
+ Bachelor’s degree in Engineering, Medical or Science (or similar) is required. Master’s degree preferred.
+ Experience in Regulatory Affairs within the medical device industry (minimum 5 years), with specific management experience, ideally in a matrix organization.
+ Experience in supporting global regulatory projects (e.g. regulatory intelligence, information systems (RIMS), data management, etc.)
+ Experience supporting end-to-end product lifecycle management for products
+ Experience in managing and maintenance of QMS processes and systems
+ Experience of working globally and understanding of global process flows
Preferred:
+ Exceptional leadership and organizational skills.
+ Proven ability to manage multiple projects and priorities.
+ Strong analytical and problem-solving abilities.
+ Strong written and verbal communication skills.
+ Strong IT skills – experience utilizing a relevant regulatory system (desirable, e.g. RIM / PLM) and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams
+ Proficiency in Project Management tools and software
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 $111,675.00 - $156,345.00 / 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) || Pennsylvania (US-PA) || Center Valley || 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 Global Regulatory Affairs Operations Manager, is responsible for overseeing and managing high-impact QARA (Quality and Regulatory) projects and initiatives, ensuring timely completion and adherence to objectives. The Operations Manager will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth and efficient delivery of QARA programs and goals. This role requires a proactive leader with exceptional organizational, analytical, and interpersonal skills who can manage multiple projects and priorities simultaneously.
Job Duties
+ Support the VP of Global Regulatory Affairs Operations in strategic planning and execution.
+ Provide data-driven insights and recommendations to inform strategic decisions.
+ Assist in the development and implementation of departmental goals.
+ Lead and manage regulatory projects, ensuring timely and successful completion.
+ Coordinate with cross-functional teams to ensure alignment and support for Regulatory initiatives.
+ Track project progress, manage timelines, and report on project status to senior management.
+ Identify areas for improvement and implement process optimization initiatives.
+ Prepare and follow up on meetings, including interdepartmental and company-wide initiatives, ensuring preparedness and proper execution.
+ Foster a collaborative and high performing culture within the team.
+ Maintain up-to-date knowledge of relevant regulations, guidelines, and industry trends.
+ Collaborate with internal and external stakeholders to ensure alignment and proper support for Regulatory and Quality initiatives.
+ Act as a liaison between the Regulatory Affairs department and other departments within the organization.
+ Represent the department in meetings, presenting updates and advocating for Regulatory priorities.
+ Monitor organizational KPIs to ensure efficiency and quality of tasks.
Job Qualifications
Required:
+ Bachelor’s degree in Engineering, Medical or Science (or similar) is required. Master’s degree preferred.
+ Experience in Regulatory Affairs within the medical device industry (minimum 5 years), with specific management experience, ideally in a matrix organization.
+ Experience in supporting global regulatory projects (e.g. regulatory intelligence, information systems (RIMS), data management, etc.)
+ Experience supporting end-to-end product lifecycle management for products
+ Experience in managing and maintenance of QMS processes and systems
+ Experience of working globally and understanding of global process flows
Preferred:
+ Exceptional leadership and organizational skills.
+ Proven ability to manage multiple projects and priorities.
+ Strong analytical and problem-solving abilities.
+ Strong written and verbal communication skills.
+ Strong IT skills – experience utilizing a relevant regulatory system (desirable, e.g. RIM / PLM) and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams
+ Proficiency in Project Management tools and software
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 $111,675.00 - $156,345.00 / 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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas
