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 Sr. Director, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively manage assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Sr. Director, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with Regulatory Affairs management, functions independently as a decision-maker on regulatory issues and assures on both a strategic and tactical level that submission/registration/renewal deadlines are met. Effectively communicates and negotiates both internally and externally with various regulatory agencies. The Sr. Director, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Essential Job Functions

• Collaboratively interface with a variety of levels on significant matters, leading the coordination of activity across organizational units
• Manage, mentor, and develop direct reports to efficiently and effectively meet individual and company goals and objectives, including accurate and on-time submissions/submission communication
• Develop, follow, and train key personnel on regulatory policies, processes and SOPs
• Develop and implement accurate and efficient regulatory strategies and update strategy based upon regulatory changes
• Determine submission and approval requirements in assigned geographies, collaborate with cross-functional teams for resourcing needs, and establish work plans/delegate assignments to Regulatory team in order to effectively meet the requirements
• Provide strategic input and technical guidance on regulatory requirements to cross functional 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, REACH, ROHS, regulatory agency guidance documents)
• Effectively and accurately write and edit technical documents
• Review and approve R&D, quality, preclinical and clinical documentation for submission filing
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
• Provide guidance in the compilation, review and submission of relevant data to complete a regulatory submission in countries where assigned
• Interact and negotiate with regulatory authorities during the development and review process to manage submission approvals
• Effectively communicate application progress to internal stakeholders
• Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies
• Support product safety evaluation and reporting as required by country regulation
• Provide regulatory input for product recalls and recall communications
• In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives
• Review and approve advertising and promotional materials to ensure regulatory compliance
• Evaluate, provide guidance and implement import/export requirements
• Identify emerging issues and regularly communicate status
• Exercise good and ethical judgment within policies and regulations
• Perform multiple tasks concurrently with accuracy
• Other duties as assigned

Requirements

• Minimum 15 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 12 years and a Master’s degree; or a PhD with 9 years experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred
• Prior positive management and mentorship experience
• Medical device software engineering background or experience is preferred
• Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
• Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions in various worldwide geographies.
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities
• Ability to think analytically with excellent problem-solving skills
• Effectively negotiate internally and externally with regulatory agencies
• Clear and effective verbal and written communication skills with diverse audiences and personnel
• Knowledge of business functions and cross group dependencies/ relationships.
• Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met
• Leadership of functional groups in the development of relevant data to complete a regulatory submission
• Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
• Effectively and positively lead direct reports while demonstrating flexibility to changing environments
• Proficient in MS Word, Excel, Adobe and Power Point

Market Range: $251,000 - $275,000
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