Regulatory Affairs Specialist
Beckman Coulter (Danaher)Bellandur, BangalorePosted 25 days agoA free account shows the apply link for every role and matches you to the ones that fit your resume.
About the role
Masimo develops medical monitoring technologies, patient monitors, sensors and related solutions. The specialist will support Indian and international regulatory filings, product registrations and responses to regulatory authorities.
What you'll do
- Compile technical files and support regulatory filings and tender submissions
- Assess local regulatory changes and communicate impacts to headquarters
- Assist global regulatory representatives with filings and health authority inquiries
- Maintain product listings and establishment registrations with Indian authorities
- Prepare responses to audit findings
Skills
Must have
- Medical device regulatory affairs
- Indian regulatory submissions
- Medical device registrations
- It equipment import/export regulations
- Bis certification
Nice to have
- Iso 13485
- India class ii medical device submissions
Who it's for
- Experience
- 2+ years
- Domain
- medical devices
About Beckman Coulter (Danaher)
Beckman Coulter (Danaher) has 52 open roles in Bangalore, at Beckman Coulter Indian Development Centre. See every Beckman Coulter (Danaher) role.
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