Senior Regulatory Affairs Specialist
Description
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.
San Francisco Bay Area (SFBA) Market Range: $101,000 - 141,500
All Other US Locations (Outside of SFBA): $88,000 - 123,000
Exact compensation may vary based on skills, experience, 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