Regulatory Affairs Specialist

MedDeviceJobs; Bengaluru; Remote; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Remote work option

Job summary

Masimo, a Danaher operating company, seeks a Regulatory Affairs Specialist to obtain and document Indian regulatory clearances for Masimo’s medical device products. You will be the sole RA representative on project teams for new products or changes, supporting APAC filings and liaising with HQ.

The ideal candidate has at least 2 years of experience in a medical device Class II/III environment with local Indian regulatory exposure, BIS certification knowledge, and ISO 13485 familiarity.

Qualifications

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

Responsibilities

• Support the APAC regulatory team with international and domestic filings, including drafting and compiling technical files and responses.
• Communicate with headquarters regulatory team on local regulation changes and impact assessment.
• Assist in filings and responses to inquiries from health authorities.
• Maintain product listings and establishment registrations with India regulatory authorities.

Skills

Regulatory affairs

Medical devices

Documentation

Regulatory submissions

Tools

BIS certification process

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 (https://danaher.com/our-businesses) 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 Syste m 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 with India regulatory authorities.

The essential requirements of the job include :

• A minimum of 2 years of work experience in a medical device Class II/ III environment.
• Local Indian Regulatory experiences in medical device industry are required
• Working knowledge of IT 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 (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home).

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.

For more information, visit www.danaher.com.