Sr. Program Lead, Regulatory Affairs

Johnson & Johnson Innovative Medicine • Irvine, CA

1d • $109,000 - $174,800 • Onsite

About The Position

Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Irvine, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Requirements

• Bachelor’s degree in engineering, Physical or Biological science or related field of study
• 6+ years’ experience in the medical device industry
• at least five (5) years in Regulatory Affairs of Medical Devices.
• Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations.
• Strong knowledge of FDA Quality System Regulation and ISO 13485 Standard is required
• Strong knowledge of EU MDR is required
• New product development experience is required
• Must be able to communicate effectively in a professional environment.
• Must be able to influence without authority.

Nice To Haves

• MS degree preferred.
• Regulatory experience with devices containing software preferred.
• International clinical and regulatory experience desired.
• Prefer experience in the cardiovascular/cardiology field.

Responsibilities

• Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
• Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
• Instill and drive a regulatory culture. Establish and support policies and standards for the measurement of new products.
• Develop IDE/510K/ and PMA submissions for class II and III medical devices.
• Conduct submission negotiations with the global regulatory agencies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
• Maintain proficiency on regulatory requirements and develop and maintain rapport with regulatory reviewers, project team members.
• Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
• Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.
• Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Benefits

• eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior