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

Olympus

Optoelectronic Equipment

Westborough, MA - USA

Senior Specialist / Project Manager

Experteer Overview

In this role you drive regulatory strategies for Olympus’ Digital Unit, ensuring global compliance for digital health products and AI-enabled technologies. You’ll collaborate with RA teams, product development, privacy, and cybersecurity to shape compliant digital health solutions. The position focuses on translating evolving regulations into actionable plans across regions. You’ll lead regulatory guidance, submissions, and due diligence for partnerships, while advancing the company’s digital health transformation.

Compensation / Benefits

Competitive salary
Annual bonus
401(k) with company match
Medical, dental, vision coverage
Paid time off and holidays
Parental leave and adoption assistance

Responsibilities

Develop and implement regulatory strategies for digital health solutions, including AI-exempt classifications and connected tech
Provide regulatory guidance and risk assessment to product development and lifecycle management
Ensure compliance with global regulations (IEC 82340-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, cybersecurity, consumer protection)
Support third-party collaboration by conducting regulatory due diligence in vendor and technology selection
Oversee regulatory submissions and compliance filings (AI risk, cybersecurity certifications, voluntary schemes)
Respond to inquiries from regulators, auditors, and privacy/cybersecurity bodies, and maintain inspection-ready documentation
Monitor and interpret evolving regional regulations, translating changes into actionable strategies
Assess impact of regulatory changes on digital health initiatives and coordinate with stakeholders to maintain compliance
Serve as liaison among RA, product development, QA, privacy, cybersecurity, and business units to align expectations
Represent Olympus in digital health and regulatory associations and stay connected to industry developments
Develop and maintain SOPs, compliance frameworks, and internal regulatory guidance for non-medical device digital health initiatives
Design and deliver training programs on compliance and ethical use of digital health technologies

Key requirements

BS or comparable
10+ years in Regulatory Affairs, preferably in medical device or digital health
3+ years focused on software-driven health technologies
Experience with regulatory compliance for digital health software not classified as medical devices, including AI-enabled consumer health platforms
Expertise in digital health regulatory affairs and knowledge of IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, cybersecurity regulations
Strong track record leading regulatory strategy for digital health in cross-functional environments (product development, data science, cybersecurity, business leadership)
Knowledge of data protection, cybersecurity, and digital trust frameworks (NIST CSF, ISO/IEC 27001, AI ethics)
Experience with digital product compliance documentation (DPIAs, AI risk classification, cybersecurity certifications) and voluntary schemes
Experience in global matrix environments, interacting with regulators, privacy authorities, and standards bodies
Experience with regulated software development environments (Agile, DevOps) and aligning requirements with sprint delivery
Ability to influence without direct authority and build cross-functional collaboration
Excellent communication and stakeholder management
Strong project management skills
Willingness to travel up to ~10%
Preferred: MS in related field
Experience with software development and cloud technologies; enterprise software and modern software engineering helpful
Experience with 510(k), De Novo, CE marking, and international software as a medical device pathways desirable