Regulatory Affairs Specialist

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.

Learn about the Danaher Business System which makes everything possible.

The Regulatory Affairs Specialist is responsible for obtaining the required regulatory clearance, maintaining the product license, and supporting RA special projects to meet the business objectives. This individual will be responsible for providing input for regulatory assessments of medical devices to ensure compliance of Masimo products with the regional requirements.

This position reports to the Regional Sr. Director, Regulatory Affairs and is part of the EMEA Regulatory Affairs team located across the region and will be an on-site role.  

In this role, you will have the opportunity to:

• Preparation and submission of national regulatory applications in Turkey, and Central Asia.
• Process and maintain registrations, renewals, changes within the region
• Assist in ensuring compliance with the MDR in the EU in addition to the national requirements.
• Provide regulatory support and guidance to the distributors within the region
• Support the RA team with day-to-day tasks, special projects.

The essential requirements of the job include:

• Minimum of 5 years of work experience in Medical Devices regulatory and quality
• Bachelor’s degree is required, preferably in Engineering, Life Sciences, Healthcare or equivalent
• Experienced in Turkey, central Asia regulatory requirements
• Excellent documentation skills including record maintenance/tracking and understanding document traceability.
• Demonstrated ability to work in a matrix environment with non-local and local leadership

• Excellent English, verbal and written communication skills

It would be a plus if you also possess previous experience in:

• Quality Systems per ISO 13485.
• Experienced in regulatory requirements for CE-marked medical devices.
• Experience in patient monitor systems, hospital-based products.
• Prior experience working within international Medical Devices organizations.

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

At Masimo we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Masimo can provide.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.