Regulatory Affairs Specialist (Bengaluru)

Regulatory Affairs Specialist (Bengaluru)

09 Oct
|
Danaher
|
Bengaluru

09 Oct

Danaher

Bengaluru

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 and documenting our mission-critical, Indian regulatory clearances for Masimo’s amazing creative medical device products. The individual will be the sole RA representative on various project teams for new products or product changes.

In this role, you will have the opportunity to:
• Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.
• Communicate with headquarter regulatory team on local regulation changes with impact assessment.
• Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.
• Assist in maintaining product listings and establishment registrations with India regulatory authorities.

The essential requirements of the job inclu

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Danaher
📍 Bengaluru

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