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.

• Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.

• Outline submission and approval requirements in assigned geographies.

• In consultation with Regulatory Affairs Management, develop sound regulatory strategies in alignment with business priorities and update strategy based upon regulatory changes.

• Provide regulatory input and technical guidance to product development and operations teams.

• Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).

• Review and approve R&D, quality, preclinical and clinical documentation for submission filing.

• In collaboration with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and EU. Support international regulatory team with submissions to other geographies (e.g., Canada, Australia, Japan, etc.).

• In consultation with responsible Regulatory Affairs Management, interact and negotiate directly with regulatory authorities during the development and review process to ensure submission approvals.

• Communicate application progress to internal stakeholders.

• Evaluate and maintain current regulatory policies, processes, procedures.

• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.

• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.

• Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner.

• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.

• Provide regulatory input for product recalls and recall communications.

• Support quality system and technical file/design dossier audits.

• Maintain regulatory files and tracking databases as required

• Evaluate import/export requirements.

• Identify emerging issues.

• Provide other US and EU country specific regulatory support.

• Effectively and accurately write and edit technical documents.

• Plan and conduct meetings, create project plans and timelines, and manage projects.

• Exercise good and ethical judgment within policy and regulations.

• Perform multiple tasks concurrently with accuracy.

• Provide guidance to functional groups in the development of relevant data to complete a regulatory submission.

• Other duties as assigned.

• 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.

Market Range:$92,000 - $134,000
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