Principal Specialist, Regulatory Affairs

Overview

Principal Specialist in Regulatory Affairs providing regulatory support for on-market products, including planning, documentation, and regulatory impact assessments.

What you'll do

• Review and provide regulatory impact assessments for product and facility changes.
• Support global submission deliverables for product variation submissions.
• Execute global plans and regulatory deliverables for sustaining variations.
• Prepare and ensure regulatory submission deliverables meet identified standards and content requirements.
• Support and help with timely query responses.
• Maintain regulatory files, tracking status, quality/compliance, and progress of documentation.
• Track, review, edit, proofread, and coordinate regulatory documentation and submissions.

What you'll need

• Bachelor’s degree with 12+ years or master’s with 8+ years’ experience in biomedical-related engineering or related fields.
• Experience in medical development, FDA regulations, and MDR.
• Understanding of basic engineering functions of medical devices.
• Knowledge and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
• Ability to identify compliance risks and escalate when necessary.
• Excellent verbal and written English communication skills for multi-location collaboration.
• Aptitude for mindfulness and attention to detail.

Details

• Based in Bangalore.
• Reports to the Manager – Systems - Patient Support Systems and Global Surgical Solutions divisions.