Are you excited by the challenge of bringing revolutionary medical technology to global markets? Our client is pioneering a new era in wearable health monitoring technology, designed to provide real-time, non-invasive diagnostics.

As the Regulatory Manager, you’ll be at the forefront of ensuring this transformative technology meets all regulatory requirements, both in the U.S. and internationally. Your expertise will be critical in bringing this life-saving technology to patients around the world.

Responsibilities

• Develop and execute regulatory strategies for FDA and EU MDR submissions for the wearable health monitoring system
• Prepare and manage documentation for 510(k) submissions, CE Mark applications, and other regulatory filings
• Collaborate with cross-functional teams to ensure compliance with global regulatory standards, including ISO 13485 and IEC 60601
• Lead interactions with the FDA, EMA, and other regulatory bodies to facilitate approvals and market access

Join a dynamic team that’s pushing the boundaries of medical technology. Apply now to help shape the future of healthcare and improve patient outcomes globally.