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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Irvine, California, United States of AmericaJob 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.
Your unique talents will help patients on their journey to wellness. 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
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
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.
Required Skills:
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 ThinkingThe anticipated base pay range for this position is :
$109,000.00 - $174,800.00Additional Description for Pay Transparency:
Skills Required
- Bachelor's degree in engineering, physical or biological science (MS preferred)
- 6+ years' experience in the medical device industry with at least 5 years in Regulatory Affairs of Medical Devices
- Experience preparing IDE, 510(k), and PMA submissions
- Proven expertise in Regulatory Affairs, submission preparation, FDA device law/regulations, worldwide regulatory procedures, project management, and negotiations
- Strong knowledge of FDA Quality System Regulation (QSR) and ISO 13485
- Strong knowledge of EU MDR
- New product development experience
- Ability to communicate effectively in a professional environment
- Ability to influence without authority
- Regulatory experience with devices containing software
- International clinical and regulatory experience
- Experience in cardiovascular/cardiology field
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
