Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave

Johnson & Johnson; Santa Clara (CA); Hybrid; USD 89,000 - 166,000; Full time

Job summary

A leading healthcare company seeks a Senior Regulatory Affairs Specialist to manage advertising and promotional compliance for its innovative medical devices. This role combines regulatory expertise with collaboration across teams, ensuring marketing materials meet both internal and government standards. Ideal candidates will have significant experience in regulatory affairs, especially within medical devices, pushing the limits of healthcare innovation.

Benefits

Medical, dental, and vision insurance

401(k) retirement plan

Annual performance bonus

Vacation and paid time off

Qualifications

• Minimum 5 years’ experience in a regulated healthcare industry.
• Experience in conducting regulatory affairs reviews in medical devices.
• Advanced knowledge of US and international medical device promotion regulations.

Responsibilities

• Review and approve advertising and promotional material for compliance.
• Collaborate with marketing and internal teams on regulatory projects.
• Maintain regulatory policies and ensure compliance with changes.

Skills

Regulatory knowledge

Analytical thinking

Problem-solving

Effective communication

Education

Bachelor’s degree

Master’s degree

PhD

Tools

MS Word

MS Excel

MS PowerPoint

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:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist, Ads/Promo Global – Shockwave 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 Regulatory Affairs Specialist assisting with Advertising and Promotion Regulatory responsibilities, works closely and partners with internal departments to help efficiently and effectively meet assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to assist in ensuring that advertising and promotion activities meet regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist (Advertising/Promotion) is responsible for reviewing and approving advertising and promotional material in compliance with internal policies and applicable government laws and regulations. This individual will support decision-making on advertising and promotion regulatory activities.

Essential Job Functions

• Collaboratively interface with Global marketing/sales personnel, other cross-functional departments and external entities, as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with commercial approvals and within established timelines.
• Research and help maintain advertising and promotion regulatory policies, processes, SOPs & business aids and assist in training key internal stakeholders.
• In collaboration with Regulatory leadership and marketing personnel, help with establishing and maintaining product claims matrices for reference.
• Conduct global 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.
• Collaborate with internal Regulatory stakeholders to help ensure that changes in product labeling are appropriately reflected in promotions and advertising.
• Work collaboratively with the commercial team and associated compliance functions to help 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 assist in developing/implementing corrective action plans for resolution of problematic issues with guidance from Regulatory leadership.
• Identify and communicate any emerging issues to Regulatory leadership and suggest solutions.
• Plan and conduct meetings, create project plans and timelines, and manage Advertising and Promotion related Regulatory projects with guidance from Regulatory Leadership.
• Exercise good and ethical judgment within policy and regulations.
• Other duties as assigned.

Requirements

• Minimum 5 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 3 years and a Master’s degree; or a PhD with 1 year experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class II/III medical device experience is preferred.
• Minimum 1-2 years of experience in conducting regulatory affairs reviews of advertising and promotional material in a medical device environment.
• Advanced knowledge of US and international medical device promotion regulations and guidelines.
• Experience with development and/or maintenance of advertising/promotion documents such as a core claims document.
• 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 for occasional meetings, approximately 1-2 times per 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 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 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 and 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 email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

Outside of Bay Area $89,000 - $143,750 Bay Area 103,000-$165,600

Additional Description for Pay Transparency: