Job Title : Senior Regulatory Affairs Specialist
The Sr. Regulatory Affairs Specialist (RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The RA specialist also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. At Philips MRI the RA Specialist 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.
Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU, Canada and Asian countries [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada, NMPA, JPAL].
Collaborate with worldwide colleagues regarding license renewals and updates
Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
Communicate application progress to internal stakeholders
Maintain regulatory files and tracking databases as required
Communicate with regulatory agencies as needed
Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
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.
Our offer
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
We offer a market conform salary
A variable bonus
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Healthy work-life balance
We are looking for
Bachelors/Master of Science degree in a software, technical, or biomedical discipline
Minimum of 6-8 years of experience in medical device regulated environment.
Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
Experience in supporting international registrations (FDA) and clinical investigations (preference)
Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference)
Knowledge of the NMPA requirements. (preference)
Excellent verbal and written communication skills (English)
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
In return, we offer you
A meaningful career, with new challenges in our dynamic organization, working in an encouraging multinational and multicultural environment. We are happy to provide you with this opportunity to work with new technologies. You will be surrounded by passionate and committed, colleagues who share your ambition to create outstanding customer experiences. Your work will be ambitious and full of opportunities for growth. Variety and challenge will be part of your daily routines.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 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. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: 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.
We want to be at our best: 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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