Philips Regulatory Affairs Manager 

Germany, Hesse 

850056420

Regulatory Affairs Manager

Your role you will be:

• Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory requirements for CE marked/FDA cleared devices in the countries of distribution in order to ensure that our products comply with the regulations.
• Presenting good understanding of UDI/ EUDAMED and GTINs.
• Expanding your regulatory knowledge of the geographies you are responsible for, liaising with local Philips Entities, Distributors, local Trade Associations and other sources of Regulatory Intelligence.
• Identifying process optimization to strengthen the International Regulatory Affairs.
• Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
• Following Quality System procedures to ensure compliance with all other applicable regulations.
• Maintaining proficiency in broad, regional regulatory requirements.
• Maintaining the regulatory and product data in cases of regulatory changes or product updates.
• Global Item Creation/ Item Setup in the PIM system.
• Local Item Creation / Item Setup in the ERP with focus on local requirements.
  

You're the right fit if you have:

• Bachelor's/ Master’s degree in engineering/ Pharmacy/ Science preferred.
• 5+ years of medical device experience with a bachelor’s degree and work experience in Regulatory Affairs, or three years of medical device experience with a Master’s degree and work experience in Regulatory Affairs.
• Excellent communication, both written and verbal, as well as experience with communication and presentations to leadership.
• Demonstrated experience in multiple types of International regulatory submissions.
• Must have a working knowledge of FDA, ISO 13485, EU MDR, and other applicable regional regulations.
• Ability to make timely decisions, sometimes with incomplete information and under tight deadlines.
• Knowledge of PC hardware/software, documentation, and archives (Proficiency in Microsoft Office Suite, particularly Word and Excel)

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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