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Principal Regulatory Affairs MR Software
14-16 years
Bangalore / Bengaluru
1 vacancy
Principal Regulatory Affairs MR Software
Philips
posted 23hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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 RD 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.
Youre 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
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Philips Benefits
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Philips Bangalore / Bengaluru Office Location
Bangalore Office
Philips India Limited
Philips Innovation Campus
MFAR Manyata Tech Park,
Nagavara,
Bangalore
Bangalore - 560045
Bangalore - 560045
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