Senior CMC Regulatory Lead – Medical Devices (Hybrid)

Organon; Florham Park (NJ); Hybrid; USD 168,000 - 286,000; Full time

Benefits offered by this job

Flexible work arrangements

Job summary

Organon is seeking a Principal Scientist, CMC Regulatory Affairs for Medical Devices & Combination Products in the United States. This role provides strategic leadership for global regulatory activities spanning development, registration, and lifecycle management of devices and drug-device combinations.

You will lead major submissions, guide health authority interactions, and partner with Product Development, Device Engineering, Quality, and Regulatory Affairs to shape strategy and ensure

Qualifications

• Bachelor's degree or higher in engineering, pharmacy, or life sciences.
• 10+ years in Regulatory Affairs or related regulated industries.
• Experience leading global regulatory strategies for devices and combination products.
• Experience with FDA and global authorities.

Responsibilities

• Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products.
• Lead major submissions and regulatory milestones.
• Engage with health authorities and manage inspections.
• Collaborate with cross-functional teams to align regulatory requirements.

Skills

Regulatory strategy

Global execution

Device leadership

Cross-functional lead

Notified bodies

Education

Bachelor's degree or higher

Advanced degree preferred

Job description

Organon is seeking a Principal Scientist, CMC Regulatory Affairs for Medical Devices & Combination Products in the United States. This role provides strategic leadership for global regulatory activities spanning development, registration, and lifecycle management of devices and drug-device combinations.

You will lead major submissions, guide health authority interactions, and partner with Product Development, Device Engineering, Quality, and Regulatory Affairs to shape strategy and ensure