Senior Specialist I - RA
Respironics Inc Bangalore
Job Description
Job Title
Senior Specialist I - RA
Job Description
Job Title : Senior Specialist I - RA
In this role, you have the opportunity to
Regulatory Affairs Manager - Ultrasound, Regulatory Operations will have an exciting opportunity to lead the Regulatory Affairs Strategy and help business with World-wide product registration, actively providing value-added regulatory affairs service and deliverables for new product introductions and product changes across the globe.Leading and supporting SAP Regulatory controls to ensure products are safe, effective, and meeting the target market Regulatory requirements.
You are responsible for- Responsible for leading the development/deployment of innovative Regulatory strategies for New Product Introductions. Collaborating with International Regulatory team to come up with creative and Innovative strategies for Accelerated Market clearances.
- Leading and driving Health Canada submissions, and updating Australia Essential Principle Checklist and DoCs.
- Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the Business Unit. Responsible for building proactive, robust, strategic relationships with external stakeholders to enable Tender support and Audit support.
- Providing MDSAP Audit support.
- Responsible for efficient SAP Regulatory Controls tracking building proactive, robust communication and ensure Products are meeting the Market regulatory requirements.
- Responsible for providing value added Regulatory service to Philips Integrated Landscape initiatives like BlueHeart SAP MBP, Windchill, RIM (Regulatory Information Management)
- Creating, updating and managing Document Change Order in Documented Information Management (DIM) tool
- Managing and driving EUDAMED, GUDID and Country UDI submissions,
- Creating and uploading and correcting DTIs (Data Trade Items) in Windchill OPDM
- You are a part of
Ultrasound Regulatory Operations team based out of Philips Innovation Campus, Bengaluru working for Philips Ultrasound LLC, USA Based organization
To succeed in this role, you should have the following skills and experience- Minimum of 8 - 12 years experience in Regulatory Affairs
- Your skills include proven experience and expertise in Global regulatory submissions, Software- IEC 62304, and Health Canada, Australia -TGA requirements, World-wide Regulatory submissions including Brazil, Russia, Singapore, Indonesia etc.,
- Exposure to Software Regulations (SaMD/Cybersecurity/SaaS) etc.,
- India Medical Device Regulations experience
- Exposure to RIMsys, Windchill etc.,
- GUDID/EUDAMED submission experience
- Experience with SAP Regulatory Controls.
- You have a minimum of a Bachelor's Degree. Master's/MBA degree desired.
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 .
- Discover .
- Learn more about .
Our newly
- adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers.
- which for full-time employees translates to 3 days working from the office and up to 2 days from home
- for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our commitment to inclusion and diversity
At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique.Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law.
For, we believe that life is better when #youareyou.
Our hybrid working model is defined in 3 ways:There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year.Ultimately creating a career that no one could have planned for. Even you.
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