Senior Regulatory Affairs Specialist - Advertising and Promotion

3 days ago

🇺🇸 United States – Remote

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $88k - $141.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Shockwave Medical

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2011

⚕️ Healthcare Insurance

🧬 Biotechnology

Description

• Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. • The Senior Regulatory Affairs Specialist facilitates advertising and promotion regulatory responsibilities and ensures compliance with regulations. • This role collaborates with marketing and internal departments to provide guidance on advertising materials. • Responsible for reviewing and approving advertising and promotional materials for compliance. • Conducts global regulatory reviews to ensure adherence to applicable regulations and corporate policies. • Identifies areas of compliance vulnerability and suggests corrective action plans. • Plans and conducts meetings, creates project plans and timelines for Advertising and Promotion related projects. • Exercises ethical judgment within policy and regulations.

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.

Benefits

• 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