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

Olympus•Westborough, MA

66d•Hybrid

About The Position

The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports regulatory activities across the Olympus Digital Unit (DU). The Digital Unit is a new, global, high-growth area at Olympus focused on how digital technologies can help transform current and future products. This position contributes to ensuring compliance of Olympus' digital health products and solutions with applicable regulatory requirements worldwide. As part of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance, prepare and maintain documentation, and support submissions related to digital health technologies, including software, and connected systems. Working closely with the DU's development teams, the RA Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving regulations, and collaborating cross-functionally with product development, quality assurance, privacy, and cybersecurity teams to ensure compliance throughout the product lifecycle.

Requirements

BS or comparable in engineering or life sciences required.
Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years with master's degree.
Previous experience working in a global environment; demonstrated sensitivity to cultural differences.
Familiarity with digital health regulatory frameworks for medical devices and frameworks outside of traditional medical devices (IEC 62304, IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act).
Experience preparing or maintaining regulatory documentation and supporting submissions or audits.
Understanding of global digital health regulatory landscapes and voluntary compliance schemes.
Effective communicator with strong organizational and documentation skills.
Ability to work independently while contributing to cross-functional project 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.
On occasion, but not more than 10 %

Nice To Haves

MS in engineering or life sciences preferred.
Experience with medical device software, including software in a medical device (SiMD) and software as a medical device (SaMD), preferred.
Knowledge of regulatory submissions such as 510(k), De Novo, or CE marking for software-based medical devices is advantageous.

Responsibilities

Participate in product teams developing new digital health technologies and connected software systems. As needed provide input to define global regulatory strategy requirements.
Participate in teams for sustaining products to provide input on global regulatory requirements.
Support regulatory submissions, filings, and responses to regulatory or auditor inquiries as directed.
Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration on for other international markets such as Japan, Middle East and Africa, Australia and Latin America.
Assist in ensuring that Olympus digital health solutions comply with applicable global regulations and standards (e.g., IEC 82304-1, IEC 81001-5-1, GDPR, HIPAA, EU AI Act, cybersecurity and consumer protection laws).
Monitor evolving regulatory frameworks related to digital health, AI, and data privacy, summarizing key updates and communicating their impact to relevant stakeholders.
Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information.
Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management.
As needed assist in the development and maintenance of regulatory standard operating procedures (SOPs), work instructions, and templates related to digital health compliance.
Assist with training activities to promote awareness of regulatory requirements and best practices among Digital Unit teams.