Your role:
The Principal Regulatory Affairs MR Software (Principal RA) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc.). The Principal RA also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan particularly in the Artificial Intelligence domain. At Philips MRI the Principal RA cooperates closely with Product Development, Clinical Science and Marketing and Sales.
Your responsibilities:
Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory requirements for CE marked/FDA cleared devices in the countries of distribution to ensure that our products comply with the regulations
Good Understanding of regulations on Artificial Intelligence globally
Implement requirements of Artificial Intelligence regulations in the MR Business
Collaborate with worldwide colleagues regarding license renewals and updates
Expanding your regulatory knowledge of the geographies you are responsible for, liaising with local Philips Entities, Distributors, local Trade Associations and other sources of Regulatory Intelligence.
Identifying Process optimization to strengthen International Regulatory Affairs.
Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
Following Quality System procedures to ensure compliance with all other applicable regulations.
Maintaining proficiency in broad, regional regulatory requirements.
Maintenance of regulatory and product data in cases of regulatory changes or product updates.
Make sure that R&D performs adequate analysis, designs, tests, codes, secures, debugs, modifies, deploys, integrates and maintains (system) software enhancements, test environment and/or new software.
Interact with users / product owners to define / adjust regulatory requirements and/or necessary modifications. Keep abreast of technical developments and practices in own field through literature, courses/trainings, technical contacts, and competitive environment.
Collaborate with cross functional team of experts to understand the requirements from end-user perspective
Deliver accurate and state-of-the-art regulatory content to ongoing NPIs and Service Packs
Investigation and resolution of customer complaints
Participate in design/code reviews and perform test automation.
Performs the role of a specialist by reviewing work products of team members
Owns and delivers assigned modules along with the team
Supports in project estimation, planning, and risk management activities.
Mentor juniors in the team on software engineering concepts
Your team:
You are part of a team of Regulatory Affairs Specialists based in Best (MRI systems), Bangalore (MRI systems software) and Pune (MRI coils). You will report to the Sr. Manager Regulatory Affairs. It’s a multicultural team and they are all enthusiastic people striving for the best regulatory compliancy.
You're the right fit if:
14+ years of medical device experience with a bachelor’s/master’s degree and work experience in Regulatory Affairs.
Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations including knowledge of global regulations on Artificial Intelligence (a.o. EU AI act).
Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs).
Excellent communication, both written and verbal, as well as experience with communication and presentations to leadership.
Demonstrated experience in multiple types of International regulatory submissions.
Ability to make timely decisions, sometimes with incomplete information and under tight deadlines.
Enthusiastic, self-motivated regulatory professional
Good communicator and team player who is able to work in a flexible and goal-oriented environment
Structured way of working
Problem solving and time management skills
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.
This role is an office 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.
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• 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 commitment to diversity and inclusion here.