Regulatory Affairs Specialist

Job title:
The Regulatory Affairs Specialist (RA specialist) coordinates and prepares regulatory plans and document packages for submissions to regulatory agencies (FDA, Health Canada, EU, Asia, etc.).
Your role:

• 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
• Good Understanding of UDI/ EUDAMED and GTINs
• 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
• Local Item Creation / Item Setup in the ERP with focus on local requirements.

You're the right fit if: (4 x bullets max)

• Bachelors degree in a software, technical, or biomedical discipline
• Minimum of 2-4 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 can work in a flexible and goal-oriented environment
• Structured way of working
• Problem-solving and time management skills

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.