Global Regulatory CMC Director - Medical Devices & Combos

Talencio; Bridgeport (CT); Hybrid; USD 150,000 - 200,000; Full time

Job summary

A global leader in medical technology is seeking a Director of Global Regulatory Chemistry, Manufacturing, and Controls (CMC) for Medical Devices. This role, based in Connecticut, focuses on leading regulatory strategies to ensure compliance and product quality, impacting patient outcomes. Candidates should have over 12 years of experience in regulatory affairs, with a particular emphasis on medical devices. This position offers a hybrid work model with relocation support.

Qualifications

• Minimum 12 years in medical device and combination product regulatory affairs.
• At least 8 years of international CMC regulatory experience.
• Strong talent development and team leadership skills.

Responsibilities

• Lead comprehensive end-to-end CMC regulatory strategies.
• Oversee the quality and timely submission of regulatory applications.
• Work closely with technical development and quality teams.

Skills

Regulatory CMC expertise

Leadership

Strategic thinking

Collaboration

Communication

Education

Bachelor's degree

Graduate degree preferred

Job description

A global leader in medical technology is seeking a Director of Global Regulatory Chemistry, Manufacturing, and Controls (CMC) for Medical Devices. This role, based in Connecticut, focuses on leading regulatory strategies to ensure compliance and product quality, impacting patient outcomes. Candidates should have over 12 years of experience in regulatory affairs, with a particular emphasis on medical devices. This position offers a hybrid work model with relocation support.