Principal Scientist, CMC Regulatory Affairs – Medical Devices & Combination Products

Job overview

The Principal Scientist, CMC Regulatory Affairs – Medical Devices & Combination Products role is hybrid in Plymouth Meeting, PA; the stated annual salary range is $168,000–$285,800. Organon develops health solutions, with a focus that includes women’s health, biosimilars, and broader healthcare needs. The role leads global regulatory strategy and execution for medical devices and drug-device combination products across development, registration, commercialization, and lifecycle management. It guides cross-functional teams through complex requirements and health-authority interactions to support regulatory outcomes, patient access, and product supply continuity.

What you'll do

• Develop and lead global CMC regulatory strategies for medical devices and combination products
• guide regulatory approaches across development, clinical investigation, registration, commercialization, and lifecycle management
• lead major submissions and milestones
• assess regulatory impacts of manufacturing, design, process, packaging, labeling, and device changes
• provide expertise on design controls, risk management, human factors, usability, clinical and performance evaluations, verification and validation, IFUs, and post-market activities
• represent Regulatory Affairs in agency interactions
• lead responses and negotiations
• align cross-functional teams
• monitor regulations and develop capabilities through mentoring and training.

What we're looking for

Skills & competencies

principal scientist

cmc regulatory affairs

medical devices

combination products

global regulatory strategy

fda

ema

health canada

hybrid

plymouth meeting pa

10% travel

organon

$168,000–$285,800/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Retirement savings plan
• paid vacation and holidays
• paid caregiver, parental, and medical leave
• medical, prescription drug, dental, and vision benefits.

Why this role

Requires a bachelor's degree or higher and at least 10 years of relevant regulatory or regulated-industry experience. Travel requirement is 10%; flexible work arrangements include hybrid and flex time.

About the employer

Organon & Co. is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.