Shockwave Medical Careers

Description

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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. 

San Francisco Bay Area (SFBA)  Market Range: $101,000 - 141,500

All Other US Locations (Outside of SFBA): $88,000 - 123,000

Exact compensation may vary based on skills, experience, and location.

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

Core Benefits: 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

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer