Regulatory Market Access Specialist

About the role

The Regulatory Market Access Specialist joins Enovis' market access team to guide new and modified medical devices through international regulatory pathways and maintain ongoing compliance. This role provides hands‑on regulatory affairs support for product approvals, renewals, and re‑registrations, ensuring that all submissions meet the required standards.

Key responsibilities

• Prepare and process documentation for new product introductions and modifications across international markets.
• Act as a core team member on sustaining and new product development projects, delivering regulatory feedback throughout the product lifecycle.
• Collaborate with the market access team and cross‑functional peers to resolve regulatory or technical queries from agencies.
• Develop and submit international regulatory registrations, licenses, and define required regulatory criteria for surgical products in assigned countries.
• Manage the release and shipment of products under regulatory control to all regions.
• Ensure continuous compliance with applicable regulations and corporate standards.

Required profile

• Strong knowledge of international medical device regulations and corporate compliance standards.
• Ability to conduct independent research and apply accepted regulatory practices.
• Experience working in cross‑functional, multi‑disciplinary project teams.

Required skills