Regulatory Market Access Specialist

About the role

The Regulatory Market Access Specialist will work in the market access team to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Market Access Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions.

What you'll do

• Handles the preparation and processing of documentation required for new product introductions and modified products in international markets
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle
• Works with market access team and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies in international…
• Prepare documentation for international regulatory registrations and licenses
• Define regulatory requirements necessary for regulatory approval of Surgical for the countries under his/her responsability

What you need

• 2–5 yrs of experience
• Compliance
• Documentation
• Regulatory affairs
• Product marketing
• Any graduate