Regulatory Affairs Program Manager Digital Strategy

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, and 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.
• Employee Resource Groups.
• Dedicated Training Resources and Learning & Development Programs.
• Paid Educational Assistance.

*US Only

**Center Valley, PA and Westborough, MA

Learn more here