Bengaluru Karnataka Sr regulatory operation specialist Jobs – 156 Open Jobs Today

Sr Regulatory Operation Specialist
Philips —Bengaluru, Karnataka
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Delta Capita —Bengaluru, Karnataka
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Accenture —Bengaluru, Karnataka
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Sr Regulatory Operation Specialist

Philips -
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Qualifications

Power BI
Microsoft Excel
SAP
Engineering
Quality management
Microsoft Office
Diagnostic evaluation
Analysis skills
Bachelor's degree
Data management
Continuous improvement
Technical writing
Cybersecurity
AI

Full job description

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 new 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 releases
Monitor implementation timelines and communicate status to stakeholders regularly

Standards & Compliance

Ensure compliance with applicable standards including IEC 62304 (software lifecycle), IEC 62366 (usability), and IEC 60601-1 (as applicable)
Stay current with evolving regulations related to SaMD, cybersecurity, AI/ML, and cloud-based medical software
Provide regulatory guidance on software validation, risk classification, and clinical evaluation

Data Analytics & Reporting

Develop and maintain dashboards and reports using tools like Power BI and Power Automate
Provide insights on regulatory metrics, submission timelines, and compliance status
Support gap assessments and continuous improvement initiatives

Documentation & Knowledge Management

Develop, review, and maintain high-quality regulatory documentation
Collaborate with SMEs to gather technical content for submissions
Establish standardized templates and documentation frameworks
Support centralized documentation repositories and data migration strategies

Required Qualifications

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field
10+ years of experience in Regulatory Affairs within the medical device industry
Strong experience with Software as a Medical Device (SaMD) regulatory submissions
Proven expertise in global regulatory frameworks (FDA, EU MDR, Health Canada, etc.)
In-depth knowledge of IEC 62304, IEC 62366, and relevant medical device standards
Experience with regulatory information management systems (e.g., RIMSYS)

Preferred Qualifications

RAPS Regulatory Affairs Certification (RAC)
Experience with AI/ML-based medical devices and associated regulatory pathways
Knowledge of cybersecurity and cloud regulations for medical devices
Familiarity with quality management systems and product lifecycle processes

Key Skills & Competencies

Regulatory strategy and submission expertise
Strong analytical and data management skills
Advanced proficiency in Microsoft Office 365 tools (Excel, Power BI, Power Automate)
Excellent documentation and technical writing skills
Stakeholder management and cross-functional collaboration
Attention to detail with a “first-time-right” mindset
Ability to work independently and drive process improvements

Work Environment & Impact

Works under general direction with a high degree of independence
Influences regulatory outcomes for global product launches
Collaborates across global teams and regulatory bodies
Contributes to compliance, innovation, and patient safety through effective regulatory practices

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

Learn more about our business .
Discover our rich and exciting history .
Learn more about our purpose .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here .

#LI-PHILIN

Apply Now

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sr regulatory operation specialist jobs in bengaluru karnataka

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Job Title

Job Description

Job Summary

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 new 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 releases

Monitor implementation timelines and communicate status to stakeholders regularly

Standards & Compliance

Ensure compliance with applicable standards including IEC 62304 (software lifecycle), IEC 62366 (usability), and IEC 60601-1 (as applicable)

Stay current with evolving regulations related to SaMD, cybersecurity, AI/ML, and cloud-based medical software

Provide regulatory guidance on software validation, risk classification, and clinical evaluation

Data Analytics & Reporting

Develop and maintain dashboards and reports using tools like Power BI and Power Automate

Provide insights on regulatory metrics, submission timelines, and compliance status

Support gap assessments and continuous improvement initiatives

Documentation & Knowledge Management

Develop, review, and maintain high-quality regulatory documentation

Collaborate with SMEs to gather technical content for submissions

Establish standardized templates and documentation frameworks

Support centralized documentation repositories and data migration strategies

Required Qualifications

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field

10+ years of experience in Regulatory Affairs within the medical device industry

Strong experience with Software as a Medical Device (SaMD) regulatory submissions

Proven expertise in global regulatory frameworks (FDA, EU MDR, Health Canada, etc.)

In-depth knowledge of IEC 62304, IEC 62366, and relevant medical device standards

Experience with regulatory information management systems (e.g., RIMSYS)

Preferred Qualifications

RAPS Regulatory Affairs Certification (RAC)

Experience with AI/ML-based medical devices and associated regulatory pathways

Knowledge of cybersecurity and cloud regulations for medical devices

Familiarity with quality management systems and product lifecycle processes

Key Skills & Competencies

Regulatory strategy and submission expertise

Strong analytical and data management skills

Advanced proficiency in Microsoft Office 365 tools (Excel, Power BI, Power Automate)

Excellent documentation and technical writing skills

Stakeholder management and cross-functional collaboration

Attention to detail with a “first-time-right” mindset

Ability to work independently and drive process improvements

Work Environment & Impact

Works under general direction with a high degree of independence

Influences regulatory outcomes for global product launches

Collaborates across global teams and regulatory bodies

Contributes to compliance, innovation, and patient safety through effective regulatory practices