Regulatory Affairs Specialist 2

The Regulatory Affairs Specialist II plays a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) products are safe, effective, and compliant with global regulatory rules and standards. This role will provide cross-team support on key compliance and regulatory activities such as SOPs (Standard Operation Procedures) tracking audits and audit readiness. 

Your responsibilities: 

• Manage regulatory master data across PLM, RIM, and ERP platforms. 

• Partner with internal teams and external stakeholders to streamline processes and solve challenges. 

• Support establishment registration, product listings, and UDI/GTIN activities, ensuring smooth regulatory filings and licenses. 

• Prepare and coordinate regulatory submissions for product licensing, driving accuracy and efficiency. 

• Review product labeling and marketing materials to ensure compliance with global standards. 

• Stay ahead of regulatory changes and contribute to continuous process improvements. 

Requirements: 

• Two or more years of experience in the medical device or other highly regulated industry where Quality Management Systems play a role in conformity with regulations. 

• A bachelor’s degree in a scientific or engineering discipline 

• Strong written, oral, and interpersonal skills to effectively compose agency submissions and collaborate cross-functionally. 

• A demonstrated ability to support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines 

• Experience in the use of MS Office and Adobe Acrobat. Knowledge of PLM software, such as Windchill is a plus. 

• High level of English, as the person will be interacting with people from different countries. 

Qualifications: 

• Knowledge in RMSYS 

• Ability to work across teams and manage multiple priorities. 

• Attention to detail and commitment to compliance.