Philips Jobs

Sr Regulatory Operation Specialist
Philips —Bengaluru, Karnataka
- Full-time
- Engineering
- Microsoft Office
- Analysis skills
7d
Complaint Handling & Vigilance Reporting Specialist
Philips —Pune, Maharashtra
- Full-time
- In-person
20h
Regulatory Affairs Manager
Philips —Pune, Maharashtra
- Full-time
- Master's degree
- Bachelor's degree
- In-person
Integration Architect
Philips —Bengaluru, Karnataka
- Full-time
- Azure
- AWS
- Mentoring
7d
Global Supplier Quality Engineer BP
Philips —Pune, Maharashtra
- Full-time
- Engineering
- Master's degree
- Bachelor's degree
20h
Product Marketing Manager-Fixed DXR
Philips —Bengaluru, Karnataka
- Full-time
- Master's degree
- Bachelor's degree
- Product management
Lead Software Technologist I
Philips —Bengaluru, Karnataka
- Full-time
- Computer Science
- Master's degree
- C++
Electrical Designer-RF Coils
Philips —Pune, Maharashtra
- Full-time
- Master's degree
- Bachelor's degree
Instituional & Government Sales Manager
Philips —Gurugram, Haryana
- Full-time
- Sales
- Master's degree
- Business development
20h
Sr Software Technologist Devops (AWS)
Philips —Bengaluru, Karnataka
- Full-time
- Computer Science
- DevOps
- Master's degree
Electrical Designer
Philips —Pune, Maharashtra
- Full-time
- Project management
- Bachelor's degree
- Agile
Digital Platforms R&D Leader
Philips —Bengaluru, Karnataka
- Full-time
- Computer Science
- Engineering
- Master's degree
14h
Manager Clinical Affairs
Philips —Pune, Maharashtra
- Full-time
- Medicine
- Doctoral degree
- Master's degree
12d
Platform Analyst – O2C – FICO
Philips —Bengaluru, Karnataka
- Full-time
- Computer Science
- Finance
- Master's degree
6d
Electrical Architect
Philips —Pune, Maharashtra
- Full-time
- Anatomy knowledge
- Master's degree
- Bachelor's degree
14d
Specialist I - OS & Security
Philips —Bengaluru, Karnataka
- Full-time
- Computer Science
- Windows
- Bachelor's degree
8d
Product Manager MR Software
Philips —Bengaluru, Karnataka
- Full-time
- Master's degree
- Project management
- Bachelor's degree
Solution Architect – Conga CLM (Techno-Functional)
Philips —Bengaluru, Karnataka
- Full-time
- Oracle
- Salesforce
- APIs
People Leader - Groups Leader and Sr. T&V architect
Philips —Pune, Maharashtra
- Full-time
- Doctoral degree
- English
- Master's degree
Mechanical Designer STET - Packaging
Philips —Pune, Maharashtra
- Full-time
- Microsoft Office
- Project management
- Agile
7d

I want to receive the latest job alerts for philips

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

philips jobs near

Supplier Quality Engineer jobs in Pune, Maharashtra

Product Manager jobs in Bengaluru, Karnataka

Engineering Lead jobs in Bengaluru, Karnataka

Mechanical Designer jobs in Pune, Maharashtra

Integration Architect jobs in Bengaluru, Karnataka

R&D Engineer jobs in Bengaluru, Karnataka

Clinic Manager jobs in Pune, Maharashtra

Platform Analyst jobs in Bengaluru, Karnataka

Product Marketing Manager jobs in Bengaluru, Karnataka

Architect jobs in Pune, Maharashtra

Governance Manager jobs in Remote

Admission Manager jobs in Pune, Maharashtra

It Manager jobs in Patna, Bihar

Housekeeping Manager jobs in Chennai, Tamil Nadu

Governance Manager jobs in Chennai, Tamil Nadu

Governance Manager jobs in Bengaluru, Karnataka

Governance Manager jobs in Delhi, Delhi

Supplier Quality Engineer jobs in Hinjewadi, Pune, Maharashtra

Diploma Civil Engineer jobs in Uttar Pradesh

Supplier Quality Engineer jobs in Maharashtra

Sr Regulatory Operation Specialist

Philips -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
7 days ago

Qualifications

Power BI
SAP
Engineering
Quality management
Microsoft Office
Analysis skills
Bachelor's degree
Product development
Less (style sheet language)
Business Administration

Full job description

Job Title

Sr Regulatory Operation Specialist

Job Description

Job Responsibilities:

International Registrations
- Upload, Verify, and Validate the data with new Regulatory Information to the RIM database
- Maintain Registration &Licensing Information
- Create Submission Packages for International Registrations
- Initiate Renewals with the countries.
- Initiate Product Change Notices per input from BU Project RA Specialist
- Establish and Maintenance of Dashboards on Product Change Notices
- Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status
International and Local Labelling
- Initiate Local label Requests through Change Requests
- Monitor the status of the Label Change requests through Implementation
- Ensure timely completion of label release happens by R&D (every 6-8 weeks.)
- Publish the status to the stakeholders on weekly/monthly
Maintenance & Reporting
- Dashboards and Reporting for International Registrations, Labelling and Gap Assessments
- Establishment Registrations & Device Listing for the USA, Canada & EU.
- Maintain repository of report Declaration of Conformity, LTFs, 510(k)s and TD Documentations
- Maintain EUDAMED, GUDID and other Regulator Databases as required for the region.

Requirements :

Degree in engineering or a related discipline.
10 years of professional experience in medical device regulatory affairs
Excellent Data Analytical skills and expert user in Office 365 tools including Power BI and Automate etc. .
Strong proven knowledge and experience international registrations
Good Documentation Practices and Independent to drive initiatives to improve the Way of Working. First time right attitude.
Experience with systems for quality management, product development, and follow-up of procedures is an advantage.
Research, outline, write, and edit content, working closely with various departments to understand Regulatory requirements
Gather information from subject-matter experts and develop, organize, and write documentation for submissions
Work with development and support leads to identify documentation repositories, revise and edit, and determining best solutions for data compilation and centralized storage
Research, create, and maintain information architecture templates that adhere to organizational and legal standards and allow for easy data migration
Develop content in alternative media forms for maximum usability, with consistent voice across all documentation

Skills-

Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
Works under general supervision within established processes and operational policies, exercising independent judgment to ensure adherence to guidelines while achieving objectives effectively.
Demonstrates basic understanding of regulator’s role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
Applies analytical skills to resolve fewer complex requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
Fosters productive internal and external working relationships to resolve mutual problems by conveying information, contributing to streamlined operations and improved outcomes, primarily communicating with internal contacts within the immediate group.
Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
Supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.
Works within standardized procedures and practices to achieve objectives and meet deadlines, making decisions that have limited impact on own work team and minimal impact on business.
Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related control processes

Preferred Education:

Bachelor's Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent

Preferred Experience:
10 years of professional experience in medical device regulatory affairs

Preferred Certification:
RAPS RAC certification

Preferred Skills:

Regulatory Requirements
Document Auditing
Data Management
Administrative Support
Product Registrations
Product Labeling
Strategy Implementation
Stakeholder Management
Regulatory Submission Documentation
Conformity Assessment
Regulatory Intelligence
Continuous Improvement

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

Refine Your Search

Sr Regulatory Operation Specialist

Complaint Handling & Vigilance Reporting Specialist

Regulatory Affairs Manager

Integration Architect

Global Supplier Quality Engineer BP

Product Marketing Manager-Fixed DXR

Lead Software Technologist I

Electrical Designer-RF Coils

Instituional & Government Sales Manager

Sr Software Technologist Devops (AWS)

Electrical Designer

Digital Platforms R&D Leader

Manager Clinical Affairs

Platform Analyst – O2C – FICO

Electrical Architect

Specialist I - OS & Security

Product Manager MR Software

Solution Architect – Conga CLM (Techno-Functional)

People Leader - Groups Leader and Sr. T&V architect

Mechanical Designer STET - Packaging

I want to receive the latest job alerts for philips

Explore jobs in more locations

Job Title

Job Description

Jobseeker tools

Employer Tools

Browse

Stay Connected