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RA Program Manager - Digital Unit

Req ID:  4553

Working Location: CALIFORNIA, SAN JOSE; Nationwide 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Regulatory Affairs (RA) Manager Digital Unit 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.

 

* Manage third party vendors as needed.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree or comparable required, Master's degree preferred.

 

* 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 Artificial Intelligence applications in Medical Devices (2-3 years).

 

* Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.

 

* Travel on occasion, no more than 10%

 

PREFERRED QUALIFICATIONS:

 

* Experience with Artificial Intelligence / Machine Learning enabled medical devices highly desirable.

 

* Demonstrated experience with standards, guidance documents and best practices related to software development, machine learning/AI and Software as a Medical Device.

 

* Experience with software Standards.

 

* Experience collaborating with development teams Agile/Digital Experience.

 

* Experience working in agile environments to ensure RA requirements are managed appropriately.

 

* Strong ability to align digital, business, and R&D leadership with global RA requirements.

 

* 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.

 

* Experience with International Regulators and Agencies, such as US-FDA, European Notified Bodies, etc.

 

* Demonstrated ability to influence colleagues without direct managerial responsibility, and build strong collaborative relationships within the organization.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

 

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

 

Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

 

Olympus…True To You. True To Society. True To LIFE.

 

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) || California (US-CA) || San Jose || 


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

Job Segment: Program Manager, QA, Quality Assurance, Manager, Management, Quality, Technology

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