Senior Manager, Regulatory Affairs - Shockwave Medical

Johnson & Johnson is hiring for a Senior Manager, Regulatory Affairs - Shockwave Medical to join our team.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

• Collaboratively interface with a variety of levels on significant matters, frequently 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 strategy based upon regulatory changes
• Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order 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, applicable 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, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., Australia, Japan, South Korea, etc.)
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
• Effectively communicate application progress to internal stakeholders
• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
• Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies
• Support product safety evaluation and reporting (e.g., PMDA/MHLW/MFDS) as required by country regulation
• Provide regulatory input for product recalls and recall communications
• In collaboration with Regulatory management, 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
• Evaluate, provide guidance and implement import/export requirements
• Identify emerging issues and regularly communicate status
• Provide other country specific regulatory support
• Plan and conduct meetings, create project plans and timelines, and manage projects
• Exercise good and ethical judgment within policies and regulations
• Preparation and support of quality management system audits for geographies outside of US and EU (e.g., MDSAP, KGMP, Japan QMS, etc.)
• Perform multiple tasks concurrently with accuracy
• Other duties as assigned

• Minimum 10 years' experience in a regulated healthcare industry with Bachelor's degree; or 8 years and a Master's degree; or a PhD with 5 years experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred
• Minimum 2 years' prior management and positive mentorship experience is preferred
• Medical device software engineering background or experience is preferred.
• Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
• Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions including international clinical trial(s) support (e.g., TGA application, ARGT application, Shonin application, Clinical Trial Notification)
• Support/experience with quality management system audits for geographies outside of US and EU (e.g., MDSAP, KGMP, Japan QMS, etc.)
• 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
• 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, accuracy of submissions, and all deadlines are met
• Leadership of functional groups in the 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.
• Proficient in MS Word, Excel, Adobe and Power Point.
• Fluency in Japanese or/and Korean language is plus, but not required.

• The anticipated base pay range for this position is $137,000 to $235,750 annually.
• 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)).

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits