Senior Regulatory Affairs Specialist

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.

💵 $101k - $141.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Shockwave Medical

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2011

⚕️ Healthcare Insurance

🧬 Biotechnology

Description

• Senior Regulatory Affairs Specialist at Shockwave Medical, Inc., pioneering IVL for cardiovascular disease treatment. • Collaboratively interface on regulatory matters, ensuring compliance with US and EU regulations. • Develop regulatory strategies, prepare submissions, and interact with authorities for approvals. • Support product development by providing regulatory input on compliance and documentation. • Manage multiple regulatory tasks while adhering to policies and maintaining licenses. • Evaluate import/export requirements and maintain regulatory files effectively.

Requirements

• Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience. • Degree in science, math, engineering, medical, or other technical fields and Class III medical device experience are preferred. • Ability to work collaboratively in a fast-paced environment while managing multiple priorities. • Must be able to travel as needed, approximately 2-3 times a year. • Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations. • Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers. • Experience with international filings is a plus (TGA, Health Canada, Shonin, CFDA, etc.). • Ability to outline sound regulatory strategy in alignment with regulations and business priorities. • Clear and effective verbal and written communication skills with diverse audiences and personnel. • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues. • Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks. • Operate as a team and/or independently while demonstrating flexibility to changing requirements. • Some medical device software engineering background or experience is preferred. • Proficiency in MS Word, Excel, Adobe and Power Point.

Benefits

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