Senior Regulatory Affairs Specialist

2 days ago

Santa Clara, California, United States Shockwave Medical Full time
Job Title: Senior Regulatory Affairs Specialist

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Job Overview

The Senior Regulatory Affairs Specialist will oversee advertising and promotional Regulatory responsibilities, working closely with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). This individual will combine knowledge of scientific, regulatory, and business issues to ensure that advertising and promotion activities meet geography-specific regulatory requirements.

Key Responsibilities
  • Collaborate with marketing/sales personnel and other cross-functional departments and external entities 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.
  • Conduct Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate policies, 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.
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 without experience; or equivalent experience.
  • Preferred degree in science, math, engineering, medical, or other technical fields and Class III medical device experience.
  • 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.
Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

  • Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
  • ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

Shockwave Medical is an EEO Employer.

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