| The Regulatory Affairs Specialist is responsible for preparation of submissions with a primary focus on EU/MDR, along with supporting all other regions registrations. Responsibilities: Regulatory support for product life cycle on product teams Prepare STED technical files Offer support and guidance for post market activities Prepare and support 510(k)Education / Experience: BS degree4 years’ experience in regulatory position in the medical device space Experience with regulatory for EU/MDR and Article 120. Experience making changes to technical files. Ability to travel internationally up to 15% is required. Experience with Class II or III medical devices. |
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