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 Regulatory Affairs Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining specific categories of regulatory documentation and data. The function of the Regulatory Affairs Operations Specialist is to provide submission publishing/verification support, and Regulatory compliance support.

Essential Job Functions

• Verify and quality review of submissions and other responses to regulatory agencies

• Publish worldwide regulatory submissions in compliance with geography-specific regulatory requirements

• Archive correspondence sent to and received from Regulatory Agencies and Notified Body

• Track original and renewals of annual licenses and registrations/listings, and collect/organize/ disseminate, when required, registration renewal documentation

• Author and route document change orders via document control system

• Provide other country specific regulatory support

• Notarize business documents

• Procure document authentications, legalizations, and certifications

• Contribute to process improvement projects

• Maintain the Department intranet up to date

• Ensure personal compliance with applicable company policies and procedures

• Provide audit backroom support

• Other duties as needed

Requirements

• Bachelor's degree or equivalent experience. Bachelor's degree in science, math, engineering, or medical fields is preferred.

• Minimum 2 years of experience in a regulatory position in a regulated healthcare industry or equivalent.

• Ability to work collaboratively in a fast-paced environment while managing multiple priorities.

• Highly proficient with MS Word, SharePoint (or equivalent), Excel, Adobe and Power Point. Proficient with Word Macros.

• Ability to work collaboratively in a fast-paced environment and to perform multiple tasks concurrently with accuracy

• Flexible with changing priorities, ability to manage multiple tasks, prioritize and schedule work to meet business needs and timelines

• Organized, detail oriented, with good planning and time management skills

• Ability to complete short- and long-term projects of moderate complexity with some guidance

• Exercise sound and ethical judgment within policy and regulations

• Ability to think analytically with good problem-solving skills

• Clear and effective verbal and written communication skills with various levels of the organization

• Notary Public is a plus

Market Range: $83,000 - $104,000
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