Job Title
Sr Regulatory Operation Specialist
Job Description
Job Summary

We are seeking an experienced Senior Regulatory Affairs Operation Specialist with deep expertise in Software as a Medical Device (SaMD) to lead and support global regulatory activities. This role is responsible for driving international product registrations, managing regulatory databases, ensuring compliance with global standards, and supporting end-to-end submission strategies for software-driven medical technologies.
The ideal candidate will have robust knowledge of global regulatory frameworks, SaMD standards, and proven experience managing complex regulatory submissions across multiple geographies.

Job Title: Sr Regulatory Operation Specialist

Key Responsibilities

Regulatory Strategy & Submissions
Lead and support international regulatory submissions for SaMD and medical device products (US, EU, Canada, and other global markets)
Support regulatory strategy development for product lifecycle activities, including current registrations, renewals, and change management





Regulatory Operations & Systems
Manage and maintain regulatory data in systems such as RIMSYS, SAP, and other regulatory databases
Ensure accurate tracking of registration and licensing status across regions
Maintain regulatory repositories including Declaration of Conformity, LTFs, 510(k)s, and Technical Documentation
Support UDI, GUDID, EUDAMED, and establishment registration activities

Product Change & Lifecycle Management
Initiate and manage Product Change Notices (PCNs) in collaboration with Business Units and Regulatory stakeholders
Assess regulatory impact of product/software changes and ensure timely submissions/notifications
Maintain dashboards to track change implementation and regulatory status

Labeling & Compliance
Initiate and manage labeling change requests and ensure compliance with local and international requirements
Coordinate with R&D; and Quality teams for timely label updates and rele

📌 Sr Regulatory Operation Specialist Bengaluru (India)
🏢 Philips
📍 India