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:

Remote (US), Santa Clara, California, United States of America

Job Description:

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

The Senior Director, Regulatory Affairs, works closely and partners with internal departments and department management to efficiently and effectively manage assigned regulatory requirements for Shockwave products. Combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with Regulatory Affairs senior management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates and negotiates both internally with product teams, domestic Regulatory leadership and externally with various distributors, license holders and regulatory agencies.

Properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs. Work collaboratively to develop, refine and sustain early strategy development for worldwide product commercialization in expanding geographies. Works collaboratively with commercial, operations and supply chain partners to establish and ensure teams meet submission and approval timelines.

Responsibilities

• Collaboratively interface with a variety of levels on significant matters, leading the coordination of activity across organizational units
• Manage, mentor, and develop direct reports to meet individual and company goals and objectives
• Develop, follow, and train key personnel on regulatory policies, processes and SOPs
• Develop and implement regulatory strategies and update strategies based upon regulatory changes
• Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to the team to effectively meet the requirements
• Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development and operations teams
• Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, appropriate sections of 21 CFR, regulatory agency guidance documents)
• Effectively and accurately write and edit technical documents
• Review and approve R& D, quality, preclinical and clinical documentation for submission filing
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
• Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
• In collaboration with cross-functional team members, direct team in approval strategy development, compilation, preparation, review and submission of regulatory submissions to authorities outside the US and EU (e.g., China, Canada, Latin America, Middle East, Asia Pacific, etc.)
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
• Effectively communicate application progress to include solutions to challenges, through directors with internal stakeholders
• Direct directors and managers in the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies
• Support product safety evaluation and reporting (e.g., Medical Device Reporting/Vigilance) as required by country regulation
• Provide regulatory input for product recalls and recall communications
• In collaboration with Regulatory leadership, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives
• Review and approve advertising and promotional materials to ensure regulatory compliance in all appropriate geographies
• Evaluate and provide guidance and solutions to team for implementation of import/export requirements
• Identify emerging issues and regularly communicate status and collaboration towards solutions as appropriate

Qualifications

• Minimum 12 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 10 years and a Master’s degree; or a PhD with 7 years experience; or equivalent experience.
• Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred

• Minimum 5 years’ prior management experience is preferred
• Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
• Strong understanding of and experience with pre- and post-market medical device regulations, requirements and submissions
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities
• Think analytically with excellent problem-solving skills
• Effectively negotiate internally and externally with regulatory agencies
• Demonstrates sound and ethical judgment in accordance with company policies and regulations
• Clear and effective verbal and written communication skills with diverse audiences and personnel
• Knowledge of business functions and cross-group dependencies/ relationships.
• Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, the accuracy of submissions, and all deadlines are met
• The leadership of functional groups in the identification of data needs and development of relevant data to complete a regulatory submission
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
• Able to effectively and positively lead direct reports while demonstrating flexibility to changing environments
• Ability to travel 20% international & domestic

This is a remote eligible role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

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.

The anticipated base pay range for this position is:

173, 000-299, 000

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. · For additional general information on Company benefits, please go to: - https: //www.careers.jnj.com/employee-benefits