The Manager, EUDAMED & UDI, Regulatory is responsible for leading and coordinating regulatory activities related to EUDAMED and Unique Device Identification (UDI) compliance. This role plays a critical part in ensuring accurate, timely, and compliant regulatory data submissions in line with EU MDR requirements. The position partners closely with Regulatory Affairs, Quality, IT, and business stakeholders to support product lifecycle management, regulatory readiness, and sustained market access across Europe. 

Key Responsibilities 

• Lead EUDAMED and UDI regulatory activities, ensuring compliance with EU MDR and related regulatory requirements. 

• Coordinate preparation, review, and submission of EUDAMED data, including actor, device, and vigilance‑related information. 

• Provide regulatory guidance and oversight for UDI implementation, maintenance, and data governance. 

• Partner with cross‑functional teams (Regulatory Affairs, Quality, IT, Supply Chain) to ensure data accuracy, consistency, and traceability. 

• Monitor changes to EU MDR, EUDAMED, and UDI requirements and assess impacts to products and processes. 

• Support internal and external audits, inspections, and regulatory assessments related to EUDAMED and UDI compliance. 

• Develop and maintain internal procedures, guidance, and training related to EUDAMED and UDI processes. 

• Drive continuous improvement initiatives to enhance regulatory data quality, efficiency, and compliance. 

Qualifications 

Education: 

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required). 

• Advanced degree or professional certification in Regulatory Affairs (preferred). 

Experience and Skills: 

Required: 

• Typically 6-8 years of progressive experience in Regulatory Affairs or regulatory data management within a regulated industry. 

• Strong knowledge of EU MDR, EUDAMED, and UDI regulatory requirements. 

• Experience coordinating regulatory data submissions and maintaining compliance records. 

• Ability to interpret regulatory requirements and translate them into operational processes. 

• Effective stakeholder management and communication skills. 

Preferred: 

• Experience in the medical device or healthcare industry. 

• Exposure to regulatory inspections, audits, or notified body interactions. 

• Experience working in a global or matrixed organization. 

• Familiarity with regulatory information management systems (RIM). 

• Demonstrated experience driving regulatory process or data governance improvements. 

• Strong attention to detail and ability to manage complex data sets. 

Other: 

• Language: English required; additional European languages preferred. 

• Travel: Limited; occasional international travel as required. 

• Certifications: RAC or equivalent preferred but not required. 

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