Global Regulatory Operations Leader

DIRECT SALES, US; Newark (DE); On-site; USD 145,000 - 242,000; Full time

Job summary

Hologic, Inc. is seeking a Senior Manager, Regulatory Operations to provide strategic and operational leadership across labeling, post-market reporting, state licensing, and UDI governance for a growing medical device portfolio.

You will lead the regulatory team, ensure global compliance, and translate complex requirements into actionable plans while collaborating with R&D, Quality, Clinical, and Manufacturing to support timely product launches and lifecycle management.

Qualifications

• Extensive knowledge of FDA 21 CFR, ISO 13485, EU MDR regulations affecting medical devices.
• Experience leading a labeling function and regulatory operations teams.
• Strong ability to interact with regulatory agencies and senior management.

Responsibilities

• Own divisional labeling process and lifecycle management.
• Oversee post-market reporting to authorities and regulatory submissions.
• Manage UDI governance and global regulatory data integrity.
• Lead cross-functional collaboration with R&D, Quality, Clinical, and Manufacturing.
• Plan, assign and direct work, develop teams, and manage budgets.

Skills

FDA knowledge

ISO 13485 knowledge

Regulatory leadership

Labeling expertise

Regulatory strategy

Education

BA/BS Degree

Master’s Degree

PhD

Job description

Hologic, Inc. is seeking a Senior Manager, Regulatory Operations to provide strategic and operational leadership across labeling, post-market reporting, state licensing, and UDI governance for a growing medical device portfolio.

You will lead the regulatory team, ensure global compliance, and translate complex requirements into actionable plans while collaborating with R&D, Quality, Clinical, and Manufacturing to support timely product launches and lifecycle management.