Senior Manager, Regulatory Affairs, Digital Health

Working Location MASSACHUSETTS, WESTBOROUGH Workplace Flexibility Hybrid Company Overview For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Job Description This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth, global innovation hub focused on how digital technologies and data-driven solutions can transform healthcare beyond traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world‑class regulatory strategies for digital health solutions, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes. Acting with agility and strategic foresight, this role helps establish best practices and scalable processes to support Olympus’ digital transformation journey. This position supports the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities, including analysis of requirements and resource allocation to support new product development teams preparing and submitting regulatory documentation for product registration/licensing in selected markets. This role involves researching, recommending, and implementing regulatory best practices balancing strategic vision with operational execution as well as interaction and liaising with R&D and Business leaders for successful market introduction. Job Duties Strategic Leadership and Portfolio Alignment Facilitate development of global regulatory strategies for medical devices and digital health solutions, including AI exempt from the medical device classification, and connected technologies aligned with the Business Unit priority. Interface with International Regulatory Affairs Team to ensure global planning considerations are included in regulatory strategy development. Partner with Business Units to review product portfolios and provide regulatory input to strategic priorities. Oversee and facilitate communication of these strategies to product teams responsible for developing new products and solutions. Lead cross‑functional teams with ownership and agility to ensure regulatory alignment with business objectives. Regulatory Guidance and Compliance Execution Provide regulatory guidance, compliance risk assessment, and strategic input to digital product development and lifecycle management. Ensure that digital health products, services, and documentation comply with applicable global regulations (IEC 82340-1, IEC 81001‑5‑1, GDPR, HIPAA, EU AI Act, cybersecurity regulations, and relevant consumer protection laws). Oversee and support regulatory submissions and compliance filings where applicable (e.g., AI risk classification documentation, cybersecurity certifications, and voluntary compliance frameworks). Respond to inquiries from regulatory authorities, auditors, or privacy/cybersecurity oversight bodies while maintaining robust documentation for inspections or audits. Monitor evolving regulatory landscapes across multiple regions (U.S., EU, Japan, APAC) and translate changes into actionable strategies. Assess the impact of regulatory changes on Olympus’ digital health initiatives and collaborate with development, privacy, and business stakeholders to adapt strategies and maintain compliance. External Engagement and Partnerships Support partnership initiatives to strengthen the Olympus Digital Health portfolio through well‑selected third‑party collaborations with vendors, ensuring regulatory due diligence in vendor and technology selection. Represent Olympus in relevant digital health and regulatory industry associations, contributing Olympus’ perspective and staying connected to external developments. Operational Excellence & Culture of Compliance Develop and maintain SOPs, compliance frameworks, and internal guidance tailored to non‑medical device digital health initiatives. Design and deliver regular training programs to ensure employees understand and follow best practices in compliance, regulatory considerations, and ethical use of digital health technologies. Review promotional materials and labeling generated by other non‑Regulatory Affairs functions, in collaboration with regional Regulatory Affairs teams, to confirm accuracy and compliance. Act as an effective business partner, driving quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus. Leadership & Team Development Mentor, manage, and develop direct reports, fostering a culture of ownership, agility, and continuous learning. Provide training and guidance on regulatory policies, processes, and SOPs to build high‑performing regulatory talent. Job Qualifications Required BS or comparable in engineering or life sciences. Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries. Minimum of 3 years focused on software‑driven health technologies. Demonstrated management experience in a matrix organization. Proven experience designing, writing, and submitting regulatory filings (e.g., 510(k), CE Mark, etc.) and securing approvals in spaces aligned to the digital health product portfolio, specifically Software as a Medical Device. Demonstrated leadership in managing the global submission process for regulatory approvals across multiple markets. Experience supporting end‑to‑end product lifecycle management for digital health solutions in major markets (North America, EMEA, Japan, China). Experience defining global regulatory strategies for digital health solutions in collaboration with functions across the business. Deep experience in regulatory compliance for digital health software not classified as medical devices, including AI‑enabled consumer health platforms, and connected technologies. Strong knowledge of frameworks and standards outside traditional medical device pathways (IEC 82304-1, IEC 81001‑5‑1, GDPR, HIPAA, EU AI Act, cybersecurity regulations, consumer protection laws). Strong track record of leading regulatory strategy for digital health solutions in cross‑functional environments (product development, data science, cybersecurity, business leadership teams). Strong understanding of data protection, cybersecurity, and digital trust frameworks (NIST Cybersecurity Framework, ISO/IEC 27001, AI ethics guidelines). Experience with digital product compliance documentation (e.g., data protection impact assessments, AI risk classification reports, cybersecurity certifications) and voluntary compliance schemes. Experience working in a global matrix environment and managing interactions with regulators, privacy authorities, and standards organizations. Skilled in working within regulated software development environments (Agile, DevOps) to ensure compliance requirements are integrated into sprint planning and delivery. Strong ability to align digital, business, and R&D leadership on global regulatory expectations, balancing compliance with innovation. Strong problem‑solving skills and an agile, ownership‑driven mindset to ensure compliance supports speed and innovation in product development. Leadership and interpersonal skills to develop and manage working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality). Excellent communication and stakeholder management skills to facilitate collaboration across teams and external partners. Strong project management skills with the ability to coordinate cross‑functional teams and manage multiple regulatory projects/initiatives. A digital‑native, change‑embracing mindset, with a passion to challenge the status quo and explore new strategic approaches. Confidence in pushing back on multiple stakeholders while maintaining productive collaboration. Excellent writing and verbal skills. On occasion, but not more than 10% of the time. Preferred MS in engineering or life sciences. RAC accreditation or post‑graduate degree. Strong understanding or hands‑on experience in software development and cloud technologies; experience with enterprise software and modern software engineering practices is desirable. Equitable Offerings Competitive salaries, annual bonus, and 401(k)* with company match. Comprehensive medical, dental, 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 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. Equal Employment Opportunity We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants requesting accommodations: Olympus is committed to the full inclusion of all qualified individuals. If a reasonable accommodation is needed, please contact View email address on click.appcast.io or call HR Compliance Manager at View phone number on click.appcast.io. Olympus provides equal employment opportunity to all applicants and employees without regard to race, color, national origin, citizenship status, religious creed, age, sex, gender identity and expression, sexual orientation, marital status, disability, genetic information, ancestry, veteran status or service in the uniformed services and any other characteristic protected by applicable federal, state or local law. #J-18808-Ljbffr