Regulatory Affairs Specialist

Danaher Corporation; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

Masimo, a Danaher operating company, seeks a Regulatory Affairs Specialist to support APAC regulatory filings and India registrations for medical device products. The role involves collaborating with global teams to compile technical files and respond to regulatory inquiries, with travel as needed.

The ideal candidate has at least 2 years in a medical device regulatory environment and familiarity with BIS certs and import/export rules. A remote work option may be available for eligible roles.

Qualifications

• Minimum 2 years of work experience in a medical device Class II/III environment.
• Local Indian regulatory experience in medical device industry is required.
• Working knowledge of IT equipment import/export rules and BIS certs application process.

Responsibilities

• Support the APAC regulatory team with international and domestic filings/registrations, including drafting and compiling of technical files, tender requests and audit responses.
• Communicate with headquarter regulatory team about local regulation changes and impact assessment.
• Assist in communications with global regulatory representatives for filings and inquiries from health authorities.
• Assist in maintaining product listings and establishment registrations with Indian regulatory authorities.

Skills

APAC regulatory experience

Medical device experience

Regulatory submissions

Education

Bachelor's degree in life sciences or engineering

Job description

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 innovative 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 withIndia regulatory authorities.

The essential requirements of the job include** :**

• A minimum of 2 yearsof work experience in a medical device Class II/ III environment.
• Local Indian Regulatory experiences in medical device industry are required
• Working knowledge ofIT equipment import/export rule and BIS certs application process.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel as needed.

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

• Experience in patient monitor systems, hospital-based products, software or electronic device products.
  • Knowledge of regulatory submission requirements for India Class II medical devices.
  • Experience in Quality Systems per ISO 13485.

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. Check out our benefits at Danaher Benefits Info.

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.