Senior Regulatory Program Lead, Medical Devices

Johnson & Johnson Innovative Medicine; Irvine (CA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Performance bonus

Medical/dental/vision benefits

401(k) retirement plan

Job summary

Johnson & Johnson MedTech is seeking a Sr Program Lead, Regulatory Affairs to join our Irvine, CA team. You will design and execute regulatory strategies for global product commercialization and lead submissions to regulatory authorities.

The role requires extensive experience in medical devices, strong knowledge of FDA regulations, EU MDR, ISO 13485, and collaboration across development, marketing, and clinical groups. Equal opportunity employer.

Qualifications

• Bachelor’s degree in engineering, physical or biological science or related field; MS preferred.
• 6+ years’ experience in the medical device industry with at least five years in Regulatory Affairs.
• Regulatory experience with devices containing software preferred.

Responsibilities

• Develop regulatory strategies to assure timely global commercialization of products.
• Interpret regulations and advise project teams and management.
• Lead IDE/510K/PMA submissions for class II and III devices.

Skills

Regulatory Affairs

FDA Knowledge

Project Management

Negotiations

Global Regulations

Regulatory Strategy

Education

Bachelor's degree in engineering/physical or biological science

MS degree preferred

Job description

Johnson & Johnson MedTech is seeking a Sr Program Lead, Regulatory Affairs to join our Irvine, CA team. You will design and execute regulatory strategies for global product commercialization and lead submissions to regulatory authorities.

The role requires extensive experience in medical devices, strong knowledge of FDA regulations, EU MDR, ISO 13485, and collaboration across development, marketing, and clinical groups. Equal opportunity employer.