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 strong 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)
🏢 Philips
📍 Bengaluru