RA Specialist II

Olympus

📍 Westborough, Massachusetts, United States 💼 Full-time 🕒 Posted June 19, 2026

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Job Description

Job Description
 Assist the Manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus
Job Duties
Participate in product teams developing new products.

As needed, provide input to define global regulatory strategy requirements.

Participate in teams for sustaining products to provide input on global regulatory requirements.

Where designated, develop coordinate prepare and maintain US medical device submissions such as 510ks and Pre-Submissions and liaise with FDA reviewers as needed.

Where designated, develop coordinate prepare and maintain medical device submissions for Canadian Class 2 3 or 4 Device License submissions.

Respond to regulatory authorities' requests for additional information.

Where designated, interface with the EU Submissions Team to support preparation of dossiers and technical files ...

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Job Details

Location Westborough, Massachusetts
Job Type Full-time
Category Life, Physical, and Social Science Technicians
Posted Date June 19, 2026
Application Deadline July 29, 2026