Senior Regulatory Strategy Lead – Medical Devices

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

Benefits offered by this job

Annual performance bonus

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k)

Job summary

Johnson & Johnson MedTech in Irvine, CA seeks a Sr Program Lead, Regulatory Affairs to guide regulatory strategy and submissions for global commercialization. You will coordinate IDE/510K/PMA filings for class II and III devices, align with FDA and international bodies, and partner with product development and clinical groups.

The role requires a strong background in medical devices, software-enabled products, and EU MDR familiarity, with a focus on timely approvals and regulatory excellence in

Qualifications

• Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations.
• Strong knowledge of Worldwide Regulatory Requirements/Procedures and Negotiations.
• Experience with ISO 13485 and EU MDR requirements.
• Regulatory leadership for medical devices with software is preferred.

Responsibilities

• Develop and implement regulatory strategies to ensure timely global product commercialization.
• Interpret and apply global regulations for project teams and management.
• Prepare IDE/510K/PMA submissions for class II and III devices.
• Lead submission negotiations with regulatory agencies and post-submission activities.

Skills

Regulatory Affairs

FDA Regulations

ISO 13485 Knowledge

EU MDR Knowledge

Project Management

Negotiations

Communication

Education

Bachelor's degree in engineering or related field

MS degree preferred

Job description

Johnson & Johnson MedTech in Irvine, CA seeks a Sr Program Lead, Regulatory Affairs to guide regulatory strategy and submissions for global commercialization. You will coordinate IDE/510K/PMA filings for class II and III devices, align with FDA and international bodies, and partner with product development and clinical groups.

The role requires a strong background in medical devices, software-enabled products, and EU MDR familiarity, with a focus on timely approvals and regulatory excellence in