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 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.
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. 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.
San Francisco Bay Area (SFBA) Market Range: $107,000 - $134,000
All Other US Locations (Outside of SFBA): $92,000 - $114,000
Exact compensation may vary based on skills, expertise, 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
Shockwave Medical
life insurance, 401(k)
Sep 24, 2024