Employer Industry: Healthcare Innovation and Medical Devices

Why consider this job opportunity:
- Salary up to $165,600
- Eligibility for an annual performance bonus based on individual and company performance
- Comprehensive employee benefits including medical, dental, vision, and life insurance
- Opportunity for career advancement and participation in long-term incentive programs
- Generous time-off benefits including vacation, sick leave, and holidays
- Flexible work arrangements with the option for remote work

What to Expect (Job Responsibilities):
- Collaborate with various departments to meet regulatory requirements for Shockwave Medical products
- Develop regulatory strategies in alignment with business priorities and navigate regulatory changes
- Provide regulatory guidance to product development and operations teams
- Prepare and submit high-quality regulatory submissions to authorities on time in the U.S. and Canada
- Maintain regulatory files and track compliance with applicable regulations and standards

What is Required (Qualifications):
- Minimum 5 years of regulatory affairs experience in the medical device industry, or equivalent experience with a Bachelor’s degree; or 3 years with a Master’s degree; or a PhD without experience
- Working knowledge of domestic and international regulatory guidelines, policies, and regulations
- Experience with pre- and post-market medical device submissions such as 510(k), IDE, and PMA
- Strong verbal and written communication skills with diverse audiences
- Highly organized with the ability to manage multiple projects and prioritize effectively

How to Stand Out (Preferred Qualifications):
- Class III medical device experience or engineering background
- Proficiency in MS Word, Excel, Adobe, and PowerPoint
- Experience with international regulatory filings (EU, UK, Australia, Japan, China, etc.)
- Ability to outline regulatory strategies in alignment with business priorities
- Flexibility to adapt to changing requirements while working independently or as part of a team

#HealthcareInnovation #MedicalDevices #RegulatoryAffairs #CareerOpportunity #CompetitiveCompensation

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