Senior Regulatory Affairs Specialist - Ad and Promo

20 hours ago

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Shockwave Medical

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1001 - 5000

Description

• Overseeing advertising and promotional Regulatory responsibilities at Shockwave Medical. • Collaboratively interface with marketing/sales and cross-functional departments. • Conduct Regulatory advertising and promotional material reviews. • Approve advertising and promotional materials for compliance. • Identify potential areas of regulatory compliance vulnerability and risk. • Plan and conduct meetings and manage projects with guidance from RA leadership. • 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. • 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.

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 • ESPP • Calm App • Pet Insurance • Student Loan Refinancing • Spot Bonus awards