Regulatory Affairs Professional

Listing expiry: 19 October 2026

About the role

Role Overview

The Regulatory Affairs Professional is responsible for analyzing global regulatory requirements for product registration, developing and maintaining processes for pre-market and post-market activities, preparing medical device submissions, maintaining product registrations, and supporting regulatory compliance throughout the product lifecycle. The role involves collaboration with regional units and internal departments to ensure that medical devices meet applicable regulatory requirements across major markets.

Key Responsibilities

• Analyze global requirements for product registration and support the creation, development, and maintenance of process frameworks for implementing necessary pre-market and post-market activities.
• Plan and prepare product-related medical device submissions in collaboration with internal regional units, in accordance with country-specific regulatory requirements.
• Maintain registrations of licensed products in markets including India, Latin America, and Asia.
• Take responsibility for component registrations in accordance with applicable standards, including BIS, CCC, and NOM, for relevant AT products.
• Advise and support internal departments, including product management, clinical marketing, marketing, and product development, in implementing and fulfilling global regulatory requirements, laws, guidelines, and regulations for medical device registration.
• Collaborate with interfacing departments using a Clinical and Product Lifecycle Management approach to optimize synergies, improve operational efficiency, and ensure regulatory compliance in major markets.
• Support the preparation of clinical evaluation reports for the EU and China, ensuring compliance with applicable regulations and timely submission to authorities.

Qualifications & Experience

• University degree in medical engineering or a comparable field of study, with relevant knowledge of imaging procedures such as radiography and fluoroscopy, and clinical interventional procedures.
• Knowledge of the relevant regulatory frameworks of the EU, China, India, and Latin America. Experience with US registrations is beneficial.
• Professional experience in regulatory affairs or comparable positions in the medical device industry.
• Familiarity with related processes, including product risk management, post-market surveillance, and product lifecycle management.
• Excellent written and spoken English communication skills.
• Ability to work collaboratively, inspire others, and accommodate different personalities within a functional team.
• Experience working in a demanding environment and pursuing aligned strategic objectives through prioritization, consolidation, and sound decision-making.
• Team-oriented approach and dedication to the organization's goals.

Additional Details

• The role requires collaboration across internal departments and regional units.
• The position emphasizes regulatory compliance, operational efficiency, and effective product lifecycle management.