Sr Manager, Regulatory Affairs (Remote) - Shockwave

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:

Baltimore, Maryland, United States, Chicago, Illinois, United States, Irvine, California, United States of America, Milpitas, California, United States of America, Mountain View, California, United States of America, Palo Alto, California, United States, Raleigh, North Carolina, United States, San Francisco, California, United States of America, San Jose, California, United States of America, Santa Clara, California, United States of America, Seattle, Washington, United States of America, South San Francisco, California, United States of America

Job Description

Johnson & Johnson is hiring for a Sr Manager, Regulatory Affairs – Shockwave Medical to join our team located in Santa Clara, CA or Remote.

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.

Position Overview

The Senior Manager, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Manager, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with responsible Regulatory Affairs 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, prepares, and negotiates both internally and externally with various regulatory agencies. The Senior Manager, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Essential Job Functions

• 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
  
  

Qualifications

• 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.
  
  

Additional Information

The anticipated salary range for this position is:

Outside of Bay Area: $137,000-$235,750

Bay Area California: $168,000-$271,400

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)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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
  

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

• Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
  
  

The anticipated base pay range for this position is :

Outside Bay Area: $137,000-$235,750 Bay Area, California: $168,000-$271,400

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.