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Senior Regulatory Affairs Specialist
6-8 years
Bangalore / Bengaluru
1 vacancy
Senior Regulatory Affairs Specialist
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.
- 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
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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