Principal Specialist, Regulatory Affairs (Medical Devices)

Location: Bangalore, Karnataka, India; onsite

Company

Develops healthcare products and solutions focused on improving patient care and sustaining lives.

What you will do

• Provide regulatory support for on-market medical devices, including change assessments, variation planning, and submission documentation.
• Prepare and coordinate global regulatory submissions, including IDE, PMA, 510(k), EU Design Dossiers and Technical Files, and Canadian Device License Applications.
• Review regulatory documentation, risk analyses, FMEA reports, labeling, advertising, promotional materials, and marketing literature.
• Coordinate with R&D, product development, clinical, marketing, and regional and global regulatory teams.
• Maintain regulatory files, document lists, submission tracking, quality records, and compliance documentation.
• Support query responses, document control, process development, and regulatory input for engineering design, development, and V&V teams.

Requirements

• Bachelor’s degree with 12+ years of experience or master’s degree with 8+ years of experience in biomedical, electrical, electronics, software, computer science, mechanical, industrial engineering, or a related field.
• Experience with medical device engineering and medical product development.
• Experience with FDA regulations and MDR, plus understanding of ISO and IEC design control procedures, regulations, and standards.
• Ability to identify compliance risks, escalate issues when necessary, and manage multiple projects simultaneously.
• Strong interpersonal, teamwork, collaboration, and written and verbal English communication skills.
• Attention to detail and ability to work with cross-functional teams across multiple locations.

Culture & Benefits

• Mission-driven healthcare environment focused on saving and sustaining lives.
• Collaborative work with R&D, clinical, marketing, engineering, and global regulatory functions.
• Opportunity to guide, support, and mentor engineering design, development, and V&V teams.
• Commitment to equal employment opportunity and reasonable accommodations.