Sr. Program Lead, Regulatory Affairs

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

Irvine, California, United States of America

Job Description

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.

Learn more at https://www.jnj.com/medtech

Job Summary

Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

Duties And Responsibilities

• 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.

Experience And Education

• Bachelor’s degree in engineering, Physical or Biological science or related field of study MS degree preferred.
• 6+ years’ experience in the medical device industry with at least five (5) years in Regulatory Affairs of Medical Devices.
• Regulatory experience with devices containing software preferred.

Required Knowledge, Skills, Abilities, Certification/Licenses And Affiliations

• 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
• International clinical and regulatory experience desired.
• Prefer experience in the cardiovascular/cardiology field.
• Must be able to communicate effectively in a professional environment.
• Must be able to influence without authority.

Additional Information

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be 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)).
• Employees are eligible for the following time off benefits:
  • 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
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00