Senior Regulatory Program Lead, MedTech

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

Benefits offered by this job

Annual bonus

Medical insurance

401(k) retirement plan

Paid time off

Job summary

Johnson & Johnson MedTech in Irvine, CA is seeking a Sr Program Lead, Regulatory Affairs to guide regulatory strategy and submissions for global commercialization of innovative medical devices. You will work with cross-functional teams to ensure compliance and timely approvals.

The role requires 6+ years in medical device regulatory affairs, including IDE/510K/PMA submissions, and experience with software-laden devices.

Qualifications

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

Responsibilities

• Ensure compliance with global regulations and regulating agencies; interpret regulations for project teams and management.
• Develop IDE/510K/ PMA submissions for class II and III medical devices.
• Conduct submission negotiations with global regulatory agencies to ensure timely approvals.
• Maintain proficiency on regulatory requirements and build rapport with reviewers and stakeholders.
• Provide continuing regulatory education to product development, marketing and clinical groups.
• Manage generation of documentation to be submitted to worldwide regulatory agencies to secure approvals.
• Collaborate with all functional groups to successfully achieve strategy.
• Ensure adherence to Health, Safety and Environmental guidelines and available resources.
• Communicate business issues or opportunities to next management level.

Skills

Regulatory Affairs

FDA regulations

Quality Systems

Project management

Education

Bachelor’s degree (engineering/physical/biological science)

MS degree preferred

Job description

Johnson & Johnson MedTech in Irvine, CA is seeking a Sr Program Lead, Regulatory Affairs to guide regulatory strategy and submissions for global commercialization of innovative medical devices. You will work with cross-functional teams to ensure compliance and timely approvals.

The role requires 6+ years in medical device regulatory affairs, including IDE/510K/PMA submissions, and experience with software-laden devices.