Philips Senior Regulatory Affairs Specialist 

India, Maharashtra 

63111004

Senior Regulatory Affairs Specialist
Job Description

Provide input for regulatory strategy during product creation and contribute to the department’s overall strategy plan.

You are responsible for

• Developing and implementing global regulatory strategy and roadmaps through a deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy
• 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, CFDA, 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 a part of

A team of regulatory affairs specialists is based in Best (MRI systems), but they are also supporting regulatory activities in Vantaa (MR Therapy) and Gainesville (MRI coils). You will be a part of a multicultural team of enthusiastic people striving for the best regulatory compliance. You will also be able to cooperate closely with Product Development, Clinical Science, and Marketing and Sales.

To succeed in this role, you should have the following skills and experience.

• Bachelor/Master of Science degree in a software, technical, or biomedical discipline
• 4-6 years minimum experience in a 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, MDD, and other global laws and regulations
• Knowledge of the CFDA requirements is a plus
• Experience in supporting international registrations (FDA) and clinical investigations is a plus
• Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) is a plus
• Excellent verbal and written communication skills (English)

In return, we offer you.

We welcome you to a challenging, innovative environment with great opportunities to explore.

Our benefits are very competitive and designed around your preferences:

• A market conform salary
• 25 Days of leave and the possibility to purchase up to 20 extra days off annually
• A variable bonus based on both Philips results and personal performance
• Extensive set of tools to drive your career, such as a personal development budget, free training, and coaching
• Solid company pension scheme and attractive collective health insurance package
• Opportunity to buy Philips shares and products with a discount
• Healthy work-life balance