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, regulatory agency guidance documents).
• In collaboration with cross-functional team members, compile, prepare, review, and submit high-quality regulatory submissions to appropriate authorities on time in assigned geographies. Support international regulatory team with submissions to other geographies as assigned.
• Communicate application progress to internal stakeholders.
• In collaboration with the Regulatory Affairs team, evaluate and maintain current regulatory policies, processes, procedures.
• Effectively communicate, prepare, and negotiate internally with cross-functional teams.
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact 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., 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
• Identify emerging issues.
• 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 4 times a year.
• Working knowledge of applicable regulatory guidelines, policies and regulations.
• Experience with pre- and post-market medical device submissions such as, EU Technical Files, Design Dossiers. Experience with international submissions is a plus (UK, EU MDR, SwissMedDO).
• 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, MS Teams, Excel, Adobe and Power Point
• Fluency in English required, along with proficiency in any additional language such as French, German, Spanish or Italian, is considered advantageous.