Philips Senior Regulatory Affairs Specialist 

India, Karnataka 

633598963

Senior Regulatory Affairs Specialist

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

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

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:

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.