Lead I - Business Analysis
BengaluruFull-time5–7 yrsPosted 1 week ago
Senior data analytics role at UST in Bengaluru. Needs 5–7 years.
About the role
The role involves defining regulatory pathways, executing submissions across multiple geographies, coordinating with health authorities and Notified Bodies, mentoring junior team members, and partnering with cross-functional teams to support regulatory compliance and successful market access.
What you'll do
- Lead the development and execution of global regulatory strategies for product registrations, renewals, and change controls across major markets
- Prepare, review, and submit regulatory dossiers in accordance with MDR, IVDR , and other regional regulatory frameworks across APAC, LATAM, EMEA, and other markets
- Regulatory query and response coordination
- Partner with R&D, Quality, and Manufacturing teams to provide regulatory input into design and development documentation
- Coordinate directly with Notified Bodies and health authorities to address queries and facilitate timely regulatory approvals
What you need
- Business analysis
- Compliance
- Regulatory affairs