Sr Regulatory Affairs Specialist - 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

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

Baltimore Maryland United States Chicago Illinois United States Irvine California United States of America Philadelphia Pennsylvania United States Portland Oregon United States Raleigh North Carolina United States San Diego California United States of America 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 US360 MN New Brighton 600 County Road D W

Job Description

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist (Ad/Promo) – Shockwave Medical to join our team located in New Brighton MN or Remote US.

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 /.

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 Regulatory Affairs Specialist overseeing advertising and promotional Regulatory responsibilities works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Regulatory Affairs Specialist combines knowledge of scientific regulatory and business issues to ensure that advertising and promotion activities meet geography specific regulatory requirements. In alignment with responsible Regulatory Affairs Management the Senior Regulatory Affairs Specialist (Advertising/Promotion) is responsible for reviewing editing and supporting compliance of SWMI advertising and promotional material and internal procedures/training. This individual supports decisionmaking for advertising and promotion regulatory activities.

Essential Job Functions

• Collaboratively interface with marketing/sales personnel and other crossfunctional departments and external entities as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with SWMI commercial approvals and within established timelines.
• Maintain geography specific advertising and promotion regulatory policies processes and SOPs and train key internal stakeholders.
• In collaboration with marketing personnel assist RA leadership in establishing and maintaining product claims matrices for worldwide reference.
• Conduct Regulatory advertising and promotional material reviews to ensure promotional scientific medical and corporate external communications are compliant with applicable regulations guidelines corporate polices and business objectives. Approve advertising and promotional materials to ensure compliance.
• Ensure that changes in product labeling are appropriately reflected in current promotions and advertising.
• Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use.
• Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and develop/implement corrective action plans for resolution of problematic issues with guidance from RA leadership.
• Identify and communicate emerging issues to RA leadership.
• Plan and conduct meetings create project plans and timelines and manage projects with guidance from RA leadership when assigned.
• Exercise good and ethical judgment within policy and regulations.
• Other duties as assigned.
  
  

Qualifications

• Minimum 5 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent experience. Degree in science math engineering medical or other technical fields and Class III medical device experience are preferred.
• Minimum 12 years of experience completing regulatory affairs reviews of advertising and promotional related material in a medical device environment. Pharmaceutical experience may be considered.
• Advanced knowledge of FDA guidelines and regulations with an emphasis on product promotional activities. Worldwide knowledge of advertising and promotional guidelines and regulations is a plus.
• Develop and/or maintain advertising/promotion documents such as a core claims document and related SOPs.
• Ability to work accurately and collaboratively in a fastpaced environment while managing multiple priorities.
• Apply effective communication skills with the ability to convey messages in a logical and concise manner.
• Ability to consistently reinforce regulatory expectations and requirements.
• Think analytically with good problem solving skills.
• Effectively negotiate internally and externally with regulatory agencies.
• Clear and effective verbal and written communication skills with diverse audiences and personnel.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Knowledge of business functions and cross group dependencies/ relationships.
• Ability to follow scientific arguments and identify regulatory scientific data needs.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Must be able to travel as needed approximately 12 times a year.
• Proficiency in MS Word Excel and PowerPoint required.
  
  

Additional Information

The anticipated salary range for this position is:

Outside of Bay Area: $89000 $143750

Bay Area California: $103000$165600

The Company maintains highly competitive performancebased 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 longterm 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 longterm 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.
  

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
  
  

The anticipated base pay range for this position is :

"Rest of US: $89000 $143750 BA: $103000$165600"

Additional Description For Pay Transparency

The Company maintains highly competitive performancebased 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.