Senior Regulatory Affairs Specialist

JOB DESCRIPTION

Job Title

Senior Regulatory Affairs Specialist

Job Description

Senior Regulatory Affairs Specialist

In this role you

The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products. This may include ventilators, oxygenators, and other accessories. The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management.

Your role:

The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW

Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.

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