Senior Manager, Regulatory Affairs, Digital Health Job Details | Olympus Corporation of the Americas

Olympus

Optoelectronic Equipment

Westborough, MA - USA

Manager / Team Leader

Experteer Overview

In this role you lead regulatory strategy and execution for Olympus’ Digital Unit, guiding digital health solutions from development to market across multiple regions. You will shape global regulatory approaches, drive cross-functional collaboration, and establish scalable processes to support digital transformation. You’ll work with R&D, business leaders, and regulatory teammates to secure approvals and ensure ongoing compliance for AI-enabled and connected health technologies. This position offers high-impact scope in a fast-growing, innovative hub and a chance to influence how digital health solutions reach patients.

Compensation / Benefits

Competitive salaries
annual bonus
401(k) with company match
comprehensive medical/dental/vision coverage
Wellbeing programs and EAP
Paid vacation and holidays

Responsibilities

Develop global regulatory strategies for medical devices and digital health solutions, including AI-exempt classifications and connected tech
Coordinate with International Regulatory Affairs to align global planning with strategy
Provide regulatory input to business units on portfolio priorities and product development
Lead cross-functional teams to ensure regulatory alignment with business objectives
Oversee regulatory guidance, risk assessment, and lifecycle compliance for digital products
Manage regulatory submissions and compliance filings (e.g., 510(k), CE Mark) across multiple markets
Monitor evolving regulations (EU, US, APAC) and translate changes into actionable plans
Mentor and develop regulatory talent and lead a culture of ownership and agility

Key requirements

BS or comparable in engineering or life sciences
Minimum 10 years of Regulatory Affairs experience, preferably in medical devices or digital health
At least 3 years focused on software-driven health technologies
Experience managing global submissions for regulatory approvals across multiple markets
Strong knowledge of regulatory frameworks for digital health software and AI-enabled platforms
Experience with Agile/DevOps in regulated software development environments
Excellent communication, stakeholder management, and project management skills
Leadership of a global regulatory strategy in cross-functional settings

leadership stakeholder management communication 510(k) and CE Mark submissions AI risk classification and data protection impact assessments IEC 82304-1, IEC 81001-5-1

Description

In this role you lead regulatory strategy and execution for Olympus’ Digital Unit, guiding digital health solutions from development to mark…

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