Lead Specialist Regulatory Affairs
GE HealthCareWhitefield, BangalorePosted 19 days agoA free account shows the apply link for every role and matches you to the ones that fit your resume.
About the role
GE HealthCare develops medical technology and digital health solutions. This specialist supports product registrations, regulatory submissions, audits, and pre- and post-market compliance for Maternal Infant Care products.
What you'll do
- Support global product registration planning and regulatory submissions
- Prepare and edit technical documentation for regulatory submissions
- Assist with notified body and quality system audits
- Monitor regulatory changes and assess impacts on products and markets
- Identify regulatory requirements, constraints, dependencies, and timelines
- Collaborate with Quality, Engineering, Manufacturing, Clinical, and Marketing teams
Skills
Must have
- Regulatory affairs
- Regulatory submissions
- Regulatory compliance
- Regulatory documentation
- Regulatory research
Who it's for
- Education
- Bachelor's degree
- Degree
- science, engineering, health sciences, legal studies, regulatory affairs, quality
- Experience
- 6 to 8 years
- Languages
- english
- Domain
- healthcare medical technology
About GE HealthCare
GE HealthCare has 92 open roles in Bangalore, at GE HealthCare Global Pvt Ltd, Summit Brigade Metropolis. See every GE HealthCare role.
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