Regulatory Affairs Program Manager Digital Strategy - Olympus Corporation of the Americas
Westborough, MA
About the Job
Working Location: MASSACHUSETTS, WESTBOROUGH; 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 Regulatory Affairs (RA) Program Manager Digital Strategy is responsible for coordinating regulatory activities across the Digital Unit (DU) including establishment and assessment of appropriate regulatory strategies and regulatory requirements. The Digital Unit is a new, global, high-growth area at Olympus focused on how Digital can help transform current and future products. This person will oversee collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will work closely with the DU's development teams. This person will research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the Digital Unit.
Job Duties
+ Ensure that Digital Unit products and documentation meet regulatory requirements for US, EU, Japan, and other key markets.
+ Support sustaining (compliance) for launched products, in conjunction with Olympus Regulatory Affairs team.
+ Provide guidance, and oversight to DU development teams in various aspects of Regulatory Affairs.
+ Build and conduct regular trainings to ensure DU employees maintain best practices in regulatory aspects of product development.
+ Support responses to regulatory body inquiries and support audits by regulatory bodies.
+ Maintain expert current knowledge of appropriate regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a medical device and Machine Learning.
+ Assess impact of changes to applicable laws and regulations and identify impact to the DU and in collaboration with other stakeholders, develop strategies to address.
+ Represent company in associations.
+ Support partnership initiatives to strengthen the Olympus Digital and Systems Integration product portfolio through well selected third party offering.
Job Qualifications
Required:
+ MS preferred, BS or comparable required
+ Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven medical devices (Software as a Medical Device) ideally with 2-3 years of experience with Artificial Intelligence / Machine Learning-enabled medical devices
+ Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.
+ Demonstrated experience with standards, guidance documents and best practices related to software development, artificial intelligence / machine learning and Software as a Medical Device.
+ Experience collaborating with development teams applying agile (software) development methodologies.
+ Experience working in agile environments to ensure RA requirements are managed appropriately as part of sprint planning and sprint execution.
+ Strong ability to align digital, business, and R&D leadership on global RA requirements.
+ Experience with International Regulators and Agencies like US-FDA, European Notified Bodies, etc.
+ Travel on occasion, but not more than 10 %.
Preferred:
+ Experience with Artificial Intelligence / Machine Learning-enabled medical devices highly desirable
+ Experience working in fast-paced, global matrix environment.
+ Excellent problem-solving skills to ensure both compliance and agility in product development Mindset & Behaviors are upheld.
+ Demonstrated ability to influence colleagues without direct managerial responsibility and build strong collaborative relationships within the organization.
+ Collaborative individual who is excited to work with cross-functional teams.
+ Passion to challenge the status quo and find new strategic directions – embraces change.
+ Comfortable pushing back on multiple parties at the same time.
+ Excellent writing and verbal skills
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) || Massachusetts (US-MA) || Westborough || 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 Regulatory Affairs (RA) Program Manager Digital Strategy is responsible for coordinating regulatory activities across the Digital Unit (DU) including establishment and assessment of appropriate regulatory strategies and regulatory requirements. The Digital Unit is a new, global, high-growth area at Olympus focused on how Digital can help transform current and future products. This person will oversee collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will work closely with the DU's development teams. This person will research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the Digital Unit.
Job Duties
+ Ensure that Digital Unit products and documentation meet regulatory requirements for US, EU, Japan, and other key markets.
+ Support sustaining (compliance) for launched products, in conjunction with Olympus Regulatory Affairs team.
+ Provide guidance, and oversight to DU development teams in various aspects of Regulatory Affairs.
+ Build and conduct regular trainings to ensure DU employees maintain best practices in regulatory aspects of product development.
+ Support responses to regulatory body inquiries and support audits by regulatory bodies.
+ Maintain expert current knowledge of appropriate regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a medical device and Machine Learning.
+ Assess impact of changes to applicable laws and regulations and identify impact to the DU and in collaboration with other stakeholders, develop strategies to address.
+ Represent company in associations.
+ Support partnership initiatives to strengthen the Olympus Digital and Systems Integration product portfolio through well selected third party offering.
Job Qualifications
Required:
+ MS preferred, BS or comparable required
+ Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven medical devices (Software as a Medical Device) ideally with 2-3 years of experience with Artificial Intelligence / Machine Learning-enabled medical devices
+ Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.
+ Demonstrated experience with standards, guidance documents and best practices related to software development, artificial intelligence / machine learning and Software as a Medical Device.
+ Experience collaborating with development teams applying agile (software) development methodologies.
+ Experience working in agile environments to ensure RA requirements are managed appropriately as part of sprint planning and sprint execution.
+ Strong ability to align digital, business, and R&D leadership on global RA requirements.
+ Experience with International Regulators and Agencies like US-FDA, European Notified Bodies, etc.
+ Travel on occasion, but not more than 10 %.
Preferred:
+ Experience with Artificial Intelligence / Machine Learning-enabled medical devices highly desirable
+ Experience working in fast-paced, global matrix environment.
+ Excellent problem-solving skills to ensure both compliance and agility in product development Mindset & Behaviors are upheld.
+ Demonstrated ability to influence colleagues without direct managerial responsibility and build strong collaborative relationships within the organization.
+ Collaborative individual who is excited to work with cross-functional teams.
+ Passion to challenge the status quo and find new strategic directions – embraces change.
+ Comfortable pushing back on multiple parties at the same time.
+ Excellent writing and verbal skills
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) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas