Regulatory Affairs Specialist
About the role
Regulatory Affairs Specialist
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 .
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 .
Not included in the source posting: about the role, benefits.
Who can apply
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