Global Regulatory Operations Lead: Labeling & UDI

Hologic, Inc.; Belgique; Sur place; EUR 124 000 - 207 000; Plein temps

Avantages offerts par ce poste

Bonus eligible

Résumé du poste

Hologic, Inc. in Belgium seeks a Senior Manager, Regulatory Operations to lead global regulatory processes, including labeling, post-market reporting, state licensing and UDI governance, enabling scalable, compliant operations for a growing medical device portfolio.

The role provides strategic counsel to the regulatory team, translating complex requirements into practical plans and coordinating with regulatory agencies across regions to ensure timely, accurate submissions and ongoing compliance.

Qualifications

• 10+ years in regulatory operations or leadership roles.
• Experience with labeling, post-market reporting and UDI governance.
• Strong knowledge of FDA, EU MDR, and ISO 13485.
• Ability to translate regulatory requirements into actionable plans.

Responsabilités

• Lead global regulatory operations and labeling processes.
• Oversee UDI governance and regulatory data integrity.
• Manage regulatory submissions and communications with agencies.
• Develop and implement procedures for regulatory operations.
• Mentor and develop regulatory staff.

Connaissances

Regulatory affairs

Leadership

FDA/ISO regulations

Labeling expertise

Data governance

Formation

BA/BS Degree

Master's Degree

PhD

Outils

FURLS

Eudamed

GUDID

Regulatory databases

Description du poste

Hologic, Inc. in Belgium seeks a Senior Manager, Regulatory Operations to lead global regulatory processes, including labeling, post-market reporting, state licensing and UDI governance, enabling scalable, compliant operations for a growing medical device portfolio.

The role provides strategic counsel to the regulatory team, translating complex requirements into practical plans and coordinating with regulatory agencies across regions to ensure timely, accurate submissions and ongoing compliance.