Regulatory Affairs Program Manager TSD Digital Strategy - Remote

Working Location: Nationwide; MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Regulatory Affairs (RA) Program Manager TSD Digital Strategy is responsible for coordinating regulatory activities across the Therapeutic Solutions Division portfolio for digital offerings including establishment and assessment of appropriate regulatory strategies and regulatory requirements. This person will oversee collaboration between internal Olympus Regulatory Affairs Teams and will work closely with the development teams. This person will research, recommend, and implement best practices, and contribute to both the strategic and operational functions.

Job Duties

•  Provide guidance to ensure software related products 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 development teams in the creation of deliverables to support regulatory submissions.
• Build and conduct regular training in the area of software development, software as a medical device and cybersecurity.
• 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 business and in collaboration with other stakeholders, develop strategies to address.
• Support responses to regulatory body inquiries and support audits by regulatory bodies.

Job Qualifications

Required:

• MS preferred, BS or comparable required.
• Minimum of 8 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).
• 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.

 

Preferred:

• Strategic Thinking Driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; makes the customer central to all thinking; keeps the focus on driving customer value; a change agent.
• 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.

 

#LI-Remote

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

 

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $100,022.00 - $140,032.00 / 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,