Sr. Program Lead, Regulatory Affairs
Johnson and Johnson
Stand out for this role — generate a tailored resume and cover letter in about a minute.
Benefits offered by this job
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
Education
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
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Regulatory Affairs Group
Regulatory Affairs
Professional
Irvine, California, United States of America
Johnson & Johnson MedTech is currently seeking a Sr Program Lead, Regulatory Affairs to join our team located in Irvine, CA.
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
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.
- 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.
- 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.
- 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.
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
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
$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
