Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
Company: Johnson & Johnson
Location: Lake Charles
Posted on: July 10, 2025
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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 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
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
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
decision-making for advertising and promotion regulatory
activities. Essential Job Functions Collaboratively interface with
marketing/sales personnel and other cross-functional 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 1-2 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 fast-paced 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 1-2 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:
$89,000- $143,750 Bay Area, California: $103,000-$165,600 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 : "Rest of US: $89,000- $143,750 BA: $103,000-$165,600"
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.
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