Principal Specialist, Regulatory Affairs (Medical Device)
Baxter · Bangalore, India
RegulatoryFull-timeCompany career page
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Role summary
Principal Specialist role providing regulatory support for on-market medical devices at Baxter's Bangalore office. Responsibilities include change assessments, submission documentation, compliance tracking, and cross-functional collaboration across R&D and regulatory teams.
What they're looking for
- Bachelor's degree with 12+ years or Master's with 8+ years in biomedical, electrical, electronics, software, mechanical, or industrial engineering
- Practitioner experience in basic medical device engineering functions
- Experience with medical device development, FDA regulations, and MDR
- Strong understanding of FDA, ISO, and IEC design control procedures and standards
- Demonstrated ability to manage multiple projects simultaneously and identify compliance risks
- Excellent verbal and written English communication skills for multi-location collaboration
What you'll be doing
- Conduct regulatory impact assessments for product and facility changes
- Prepare and support global submission deliverables for variation submissions and supplements
- Maintain regulatory files and track documentation status, quality, and compliance progress
- Collaborate with product development, clinical, and marketing teams to provide regulatory input and guidance
- Interface with Global Business Unit and Regional Regulatory teams to ensure alignment with business requirements
Privacy & handoff
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