Regulatory Ops Lead — RIM, PIM & EUDAMED

BD; Franklin Lakes (NJ); Sur place; USD 138 000 - 220 000; Plein temps

Résumé du poste

BD is hiring for a senior regulatory operations leader to support MDS Regulatory Affairs. You will own governance for RIM systems, lead PIM activities, and drive coordination of regulatory data across the business.

The role requires extensive experience with regulatory data governance and transformation initiatives. Remote work is limited with strong emphasis on on-site collaboration; you will engage cross-functional teams to ensure compliance, efficiency, and readiness for global regulatory

Qualifications

• 8+ years of experience in Regulatory Affairs or related medical device functions.
• Demonstrated experience with regulatory systems, regulatory data governance, and business process management.
• Experience leading cross-functional initiatives and projects.

Responsabilités

• Lead regulatory business operations activities supporting the MDS Regulatory Affairs organization.
• Serve as governance lead for Regulatory Information Management (RIM) systems and processes.
• Lead all aspects of Product Information Management (PIM) activities and ensure data alignment with business needs.
• Oversee DEO governance, maintenance, and regulatory standards guidance.
• Drive EUDAMED implementation, governance, compliance, and readiness activities.
• Develop regulatory metrics, dashboards, and performance indicators.

Connaissances

Regulatory affairs expertise

Cross-functional leadership

Digital transformation experience

Project management

Formation

Bachelor's degree in Science, Engineering, Regulatory Affairs, Business Administration, Information Systems, or related discipline

Outils

RIM systems

Description du poste

BD is hiring for a senior regulatory operations leader to support MDS Regulatory Affairs. You will own governance for RIM systems, lead PIM activities, and drive coordination of regulatory data across the business.

The role requires extensive experience with regulatory data governance and transformation initiatives. Remote work is limited with strong emphasis on on-site collaboration; you will engage cross-functional teams to ensure compliance, efficiency, and readiness for global regulatory