At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https: //www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America, Jacksonville, Florida, United States of America, Milpitas, California, United States of America

Job Description:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

Johnson & Johnson is recruiting a strategic, results-driven Vice President of Global Regulatory Affairs to lead our global regulatory strategy, ensuring compliance and fostering innovation in our J& J MedTech Vision portfolio. This position can be located in Jacksonville FL, Irvine CA, or Milpitas, CA.

Purpose:

You will report directly to the Global Head of R& D, J& J Vision. The Johnson & Johnson MedTech Vision VP, Global Regulatory Affairs will lead the global regulatory strategy for the vision portfolio, ensuring compliance and facilitating product approvals worldwide. This senior leader will guide regulatory strategy, manage agency relationships, and oversee the regulatory organization for J& J MedTech Vision.

You will be responsible for:

• Serves as the overall Regulatory Affairs leader for J& J MedTech Vision business.
• Liaises with business stakeholders to establish and execute global regulatory strategies for new and existing products.
• Provides direction and leadership to the regulatory teams in the development and execution of global regulatory strategies and processes.
• Enables timely regulatory approvals for product launches in key markets with appropriate sequence of global roll-out.
• Partners with Regulatory Policy and Government Affairs to monitor the global regulatory environment and provide impact assessments of new and changing regulations on the company's portfolio of products and help drive strategies to achieve a competitive advantage and benefit for the patients.
• Take initiatives in Regulatory Policy shaping and advocacy activities with regulatory health authorities on a global and regional basis.
• Ensures aligned and coordinated contact and communication with global and regional/local regulatory agencies.
• Manages, overseas, and balances regulatory resource allocation across portfolio.
• Ensures appropriate regulatory framework (policies, processes, procedures, training, etc.) exist to facilitate efficiency and regulatory compliance.

Requirements:

• Bachelor’s Degree in Scientific Discipline is required.
• 15 years of regulatory affairs working experience in the health industry, of which a minimum of 10 years in medical device industry.
• Experience with PMAs, 510Ks, IDEs, Q-Subs and international registrations/renewals is required.
• Experience with FDA, Notified Bodies, EUMDR, PMDA and NMPA/CMDE required.
• Expert knowledge, understanding, and application of principles, concepts and practice of worldwide government regulations is required.
• Strong strategic thinking and business acumen is required.
• Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio is required.
• Strong organizational, communication, negotiation and interpersonal skills is required.
• Ability to effectively negotiate and influence leadership, affiliates, regulatory agencies, and industry to ensure that regulatory requirements and business needs are met is required.
• Track record of inclusive leadership and talent development is required, including leading a global regulatory team.
• Willingness to work across multiple time zones.

Preferred Requirements:

• Advanced Degree in a Scientific Discipline is preferred.
• Experience in eye health industry is strongly preferred.

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 and 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, external applicants please contact us via https: //www.jnj.com/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

The expected base pay range for this position is $289, 000 to $391, 000. The expected base pay range for this position in the Bay area is $332, 350 to $449, 650.

Additional Description for Pay Transparency:

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. Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits