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 Principal Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. Under direction of responsible Regulatory Affairs Management, works independently with minimal oversight, acts as a decision-maker on regulatory issues, assures that registration/renewal and other deadlines are met, and supports new product development, post-approval change management and J&J integration as assigned.
Essential Job Functions
- Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.
- Develop regulatory policies, processes and SOPs and may train key personnel on them.
- Lead and execute assigned integration projects.
- Lead implementation of continuous improvement updates to internal policy and procedures in response to changing regulations, standards, internal and external audits.
- Develop regulatory strategies and update strategy based upon regulatory changes.
- Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders
- Provide input and technical guidance on regulatory requirements 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, REACH, 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/or submit regulatory submissions to authorities in and outside the US, as assigned (e.g., EU, Canada, Australia, Japan, etc.).
- Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals.
- Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
- Oversee the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies.
- Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
- Provide regulatory input for product recalls and recall communications.
- Review and approve advertising and promotional materials to ensure regulatory compliance.
- Evaluate import/export requirement.
- Identify emerging issues.
- Provide other 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.
Requirements
- Typically requires a minimum of 10 years of related experience with a Bachelor's degree; or 8 years and a Master's degree; or a PhD with 4 years experience; or equivalent 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.
- Detailed 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, and international filings (TGA, Health Canada, Shonin, CFDA, etc.).
- Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
- Think analytically with good 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.
- Leadership of functional groups in the development of relevant data to complete a regulatory submission.
- Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- 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 and Power Point required.
San Francisco Bay Area (SFBA) Market Range: $121,000 - $151,000
All Other US Locations (Outside of SFBA): $102,000 - $128,000
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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer |
Shockwave Medical
life insurance, 401(k)
Nov 15, 2024